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FDA 510(k)

EVRON GEL

K-Number: K961222 · 1996-06-26

ApplicantPharmaceutical Innovations, Inc.
Decision Date1996-06-26
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EVRON GEL is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaceutical Innovations, Inc.. It received FDA 510(k) clearance on 1996-06-26 under 510(k) number K961222. 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 EVRON GEL?

EVRON GEL is a medical device that received FDA 510(k) clearance on 1996-06-26. The listed applicant is Pharmaceutical Innovations, Inc.. The 510(k) number is K961222.

When did EVRON GEL receive FDA 510(k) clearance?

EVRON GEL received FDA 510(k) clearance on 1996-06-26, under 510(k) number K961222.

Who is the listed applicant for EVRON GEL?

The FDA 510(k) record lists Pharmaceutical Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVRON GEL?

The FDA product code for EVRON GEL 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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Other records listing Pharmaceutical Innovations, Inc. 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.

K163027Ultra/Phonic Free Conductivity GelK163026Ultra/Phonic Scanning GelK163024Ultra/Phonic Conductivity GelK163023Other-Sonic Transmission Gel

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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