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FDA 510(k)

SANA-LUBE

K-Number: K853653 · 1985-11-13

ApplicantHuntington Laboratories, Inc.
Decision Date1985-11-13
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SANA-LUBE is the device name listed in this FDA 510(k) record. The listed applicant is Huntington Laboratories, Inc.. It received FDA 510(k) clearance on 1985-11-13 under 510(k) number K853653. 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 SANA-LUBE?

SANA-LUBE is a medical device that received FDA 510(k) clearance on 1985-11-13. The listed applicant is Huntington Laboratories, Inc.. The 510(k) number is K853653.

When did SANA-LUBE receive FDA 510(k) clearance?

SANA-LUBE received FDA 510(k) clearance on 1985-11-13, under 510(k) number K853653.

Who is the listed applicant for SANA-LUBE?

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

What is the FDA product code for SANA-LUBE?

The FDA product code for SANA-LUBE is KMJ.

Other records listing Huntington Laboratories, 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.

K960580BEAUCOUP GENERAL PURPOSE DISINFECTANTK960583MATAR GENERAL PURPOSE DISINFECTANTK960582ASCEND GENERAL PURPOSE DISINFECTANTK953011FORMULATION HWS-64 EPA REG. NO. 47371-131K953010FORMULATION HWS-256 EPA REG. NO. 47371-129K953009FORMULATION HWS-128 EPA REG. NO. 47371-130

View all 7 devices →

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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