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FDA 510(k)

CONDOM-MATE VAGINAL LUBRICANT

K-Number: K881338 · 1988-05-16

ApplicantUpsher-Smith Laboratories, Inc.
Decision Date1988-05-16
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CONDOM-MATE VAGINAL LUBRICANT is the device name listed in this FDA 510(k) record. The listed applicant is Upsher-Smith Laboratories, Inc.. It received FDA 510(k) clearance on 1988-05-16 under 510(k) number K881338. The device is classified under product code KMJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONDOM-MATE VAGINAL LUBRICANT?

CONDOM-MATE VAGINAL LUBRICANT is a medical device that received FDA 510(k) clearance on 1988-05-16. The listed applicant is Upsher-Smith Laboratories, Inc.. The 510(k) number is K881338.

When did CONDOM-MATE VAGINAL LUBRICANT receive FDA 510(k) clearance?

CONDOM-MATE VAGINAL LUBRICANT received FDA 510(k) clearance on 1988-05-16, under 510(k) number K881338.

Who is the listed applicant for CONDOM-MATE VAGINAL LUBRICANT?

The FDA 510(k) record lists Upsher-Smith Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONDOM-MATE VAGINAL LUBRICANT?

The FDA product code for CONDOM-MATE VAGINAL LUBRICANT is KMJ.

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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Related Devices (Code: KMJ)

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.

K131617COLONGLIDE(R) LUBRICANTPediatric Pharmaceuticals, Inc.K121390LUBE JELLY SURINGENurse Assist, Inc.K113689DUKAL LUBRICATING JELLYDukal CorporationK112110STERILE LUBRICATING JELLYJianerkang Medical Dressing CompanyK103718DYNACOR LUBRICATION GELMedline Industries, Inc.K101522ULTRA SEAL STERILE LUBRICATING JELLYUltra Seal Corporation

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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