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FDA 510(k)

PROPHALACTICS

K-Number: K770412 · 1977-06-17

ApplicantJamar Health Products
Decision Date1977-06-17
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PROPHALACTICS is the device name listed in this FDA 510(k) record. The listed applicant is Jamar Health Products. It received FDA 510(k) clearance on 1977-06-17 under 510(k) number K770412. 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 PROPHALACTICS?

PROPHALACTICS is a medical device that received FDA 510(k) clearance on 1977-06-17. The listed applicant is Jamar Health Products. The 510(k) number is K770412.

When did PROPHALACTICS receive FDA 510(k) clearance?

PROPHALACTICS received FDA 510(k) clearance on 1977-06-17, under 510(k) number K770412.

Who is the listed applicant for PROPHALACTICS?

The FDA 510(k) record lists Jamar Health Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROPHALACTICS?

The FDA product code for PROPHALACTICS 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 Jamar Health Products 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.

K772336GLOVE & LATEX FINGER COTSK771757EXAM GLOVES

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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