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FDA 510(k)

ULTRA SEAL STERILE LUBRICATING JELLY

K-Number: K101522 · 2010-12-23

ApplicantUltra Seal Corporation
Decision Date2010-12-23
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ULTRA SEAL STERILE LUBRICATING JELLY is the device name listed in this FDA 510(k) record. The listed applicant is Ultra Seal Corporation. It received FDA 510(k) clearance on 2010-12-23 under 510(k) number K101522. 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 ULTRA SEAL STERILE LUBRICATING JELLY?

ULTRA SEAL STERILE LUBRICATING JELLY is a medical device that received FDA 510(k) clearance on 2010-12-23. The listed applicant is Ultra Seal Corporation. The 510(k) number is K101522.

When did ULTRA SEAL STERILE LUBRICATING JELLY receive FDA 510(k) clearance?

ULTRA SEAL STERILE LUBRICATING JELLY received FDA 510(k) clearance on 2010-12-23, under 510(k) number K101522.

Who is the listed applicant for ULTRA SEAL STERILE LUBRICATING JELLY?

The FDA 510(k) record lists Ultra Seal Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRA SEAL STERILE LUBRICATING JELLY?

The FDA product code for ULTRA SEAL STERILE LUBRICATING JELLY is KMJ.

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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.K092488DYNAREX STERILE LUBRICATING JELLYDynarex 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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