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FDA 510(k)

OPERAND LUBRICATING JELLY

K-Number: K912975 · 1991-09-27

ApplicantGeneral Medical Co.
Decision Date1991-09-27
Product CodeKMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OPERAND LUBRICATING JELLY is the device name listed in this FDA 510(k) record. The listed applicant is General Medical Co.. It received FDA 510(k) clearance on 1991-09-27 under 510(k) number K912975. 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 OPERAND LUBRICATING JELLY?

OPERAND LUBRICATING JELLY is a medical device that received FDA 510(k) clearance on 1991-09-27. The listed applicant is General Medical Co.. The 510(k) number is K912975.

When did OPERAND LUBRICATING JELLY receive FDA 510(k) clearance?

OPERAND LUBRICATING JELLY received FDA 510(k) clearance on 1991-09-27, under 510(k) number K912975.

Who is the listed applicant for OPERAND LUBRICATING JELLY?

The FDA 510(k) record lists General Medical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPERAND LUBRICATING JELLY?

The FDA product code for OPERAND LUBRICATING JELLY 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 General Medical Co. 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.

K926269PROCEDURE KITK912132OPERAND LUBRICATING JELLYK903669GENESIS INSUFFLATING CATHETERK900110OPERAND* LUBRICATING JELLYK853635SUBDERM TMK844652C.A.S.E. CONTAINER

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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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