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FDA 510(k)

GOOD LUBRICATIONS

K-Number: K020586 · 2003-01-24

ApplicantBiofilm, Inc.
Decision Date2003-01-24
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GOOD LUBRICATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Biofilm, Inc.. It received FDA 510(k) clearance on 2003-01-24 under 510(k) number K020586. 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 GOOD LUBRICATIONS?

GOOD LUBRICATIONS is a medical device that received FDA 510(k) clearance on 2003-01-24. The listed applicant is Biofilm, Inc.. The 510(k) number is K020586.

When did GOOD LUBRICATIONS receive FDA 510(k) clearance?

GOOD LUBRICATIONS received FDA 510(k) clearance on 2003-01-24, under 510(k) number K020586.

Who is the listed applicant for GOOD LUBRICATIONS?

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

What is the FDA product code for GOOD LUBRICATIONS?

The FDA product code for GOOD LUBRICATIONS is KMJ.

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Other records listing Biofilm, Inc. as applicant

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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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