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FDA 510(k)

CATHEJELL S STERILE LUBRICATING JELLY

K-Number: K935548 · 1994-03-30

ApplicantPharmazeutische Fabrik Montavit GmbH
Decision Date1994-03-30
Product CodeFHX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CATHEJELL S STERILE LUBRICATING JELLY is the device name listed in this FDA 510(k) record. The listed applicant is Pharmazeutische Fabrik Montavit GmbH. It received FDA 510(k) clearance on 1994-03-30 under 510(k) number K935548. The device is classified under product code FHX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHEJELL S STERILE LUBRICATING JELLY?

CATHEJELL S STERILE LUBRICATING JELLY is a medical device that received FDA 510(k) clearance on 1994-03-30. The listed applicant is Pharmazeutische Fabrik Montavit GmbH. The 510(k) number is K935548.

When did CATHEJELL S STERILE LUBRICATING JELLY receive FDA 510(k) clearance?

CATHEJELL S STERILE LUBRICATING JELLY received FDA 510(k) clearance on 1994-03-30, under 510(k) number K935548.

Who is the listed applicant for CATHEJELL S STERILE LUBRICATING JELLY?

The FDA 510(k) record lists Pharmazeutische Fabrik Montavit GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATHEJELL S STERILE LUBRICATING JELLY?

The FDA product code for CATHEJELL S STERILE LUBRICATING JELLY is FHX.

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Related Devices (Code: FHX)

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.

K081990LUBRICANO STERILE GELFarco Pharma GmbHK951713BUTTON LUBRICATORFibertech Instruments, Inc.K912132OPERAND LUBRICATING JELLYGeneral Medical Co.K780386K-Y LUBRICATING JELLYJohnson & Johnson Professionals, Inc.K771364LUBE JELTravenol Laboratories, S.A.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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