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FDA 510(k)

LUBRICANO STERILE GEL

K-Number: K081990 · 2008-12-05

ApplicantFarco Pharma GmbH
Decision Date2008-12-05
Product CodeFHX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LUBRICANO STERILE GEL is the device name listed in this FDA 510(k) record. The listed applicant is Farco Pharma GmbH. It received FDA 510(k) clearance on 2008-12-05 under 510(k) number K081990. 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 LUBRICANO STERILE GEL?

LUBRICANO STERILE GEL is a medical device that received FDA 510(k) clearance on 2008-12-05. The listed applicant is Farco Pharma GmbH. The 510(k) number is K081990.

When did LUBRICANO STERILE GEL receive FDA 510(k) clearance?

LUBRICANO STERILE GEL received FDA 510(k) clearance on 2008-12-05, under 510(k) number K081990.

Who is the listed applicant for LUBRICANO STERILE GEL?

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

What is the FDA product code for LUBRICANO STERILE GEL?

The FDA product code for LUBRICANO STERILE GEL is FHX.

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Other records listing Farco Pharma GmbH 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.

K083358LUBRICANO-ULTRASOUND

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.

K951713BUTTON LUBRICATORFibertech Instruments, Inc.K935548CATHEJELL S STERILE LUBRICATING JELLYPharmazeutische Fabrik Montavit GmbHK912132OPERAND 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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