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FDA 510(k)

LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10

K-Number: K851290 · 1985-05-22

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

Device Summary

LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10 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 K851290. 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 LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10?

LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10 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 K851290.

When did LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10 receive FDA 510(k) clearance?

LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10 received FDA 510(k) clearance on 1985-05-22, under 510(k) number K851290.

Who is the listed applicant for LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10?

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 LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10?

The FDA product code for LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10 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.

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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-20K851291LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30

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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