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FDA 510(k)

LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30

K-Number: K851291 · 1985-05-22

ApplicantManexim Multicorp, Ltd.
Decision Date1985-05-22
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30 is the device name listed in this FDA 510(k) record. The listed applicant is Manexim Multicorp, Ltd.. It received FDA 510(k) clearance on 1985-05-22 under 510(k) number K851291. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30?

LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30 is a medical device that received FDA 510(k) clearance on 1985-05-22. The listed applicant is Manexim Multicorp, Ltd.. The 510(k) number is K851291.

When did LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30 receive FDA 510(k) clearance?

LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30 received FDA 510(k) clearance on 1985-05-22, under 510(k) number K851291.

Who is the listed applicant for LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30?

The FDA 510(k) record lists Manexim Multicorp, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30?

The FDA product code for LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30 is HIS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Manexim Multicorp, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K863707LOVESAFE CONTRACEPTIVE CONDOMS, TYPE SC-40K863706LOVESAFE CONTRACEPTIVE CONDOMS, TYPE NL-50K851292LOVESAFE DOTTY CONDOM ONE DZ. CODOMS/BOX, DC-20K851290LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10

Related Devices (Code: HIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MOShanghai Personage Hygiene Products Co., Ltd.K252622Male Latex Condom HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex LimitedK250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc.K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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