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FDA 510(k)

MINNOW PENILE IMPLANT PROTECTOR

K-Number: K904262 · 1990-12-13

ApplicantRuja-Med Medical Marketing
Decision Date1990-12-13
Product CodeFAE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MINNOW PENILE IMPLANT PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Ruja-Med Medical Marketing. It received FDA 510(k) clearance on 1990-12-13 under 510(k) number K904262. The device is classified under product code FAE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINNOW PENILE IMPLANT PROTECTOR?

MINNOW PENILE IMPLANT PROTECTOR is a medical device that received FDA 510(k) clearance on 1990-12-13. The listed applicant is Ruja-Med Medical Marketing. The 510(k) number is K904262.

When did MINNOW PENILE IMPLANT PROTECTOR receive FDA 510(k) clearance?

MINNOW PENILE IMPLANT PROTECTOR received FDA 510(k) clearance on 1990-12-13, under 510(k) number K904262.

Who is the listed applicant for MINNOW PENILE IMPLANT PROTECTOR?

The FDA 510(k) record lists Ruja-Med Medical Marketing as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINNOW PENILE IMPLANT PROTECTOR?

The FDA product code for MINNOW PENILE IMPLANT PROTECTOR is FAE.

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Related Devices (Code: FAE)

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.

K183619Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm DeviceBoston Scientific CorporationK181673Rigi10 Malleable Penile ProsthesisRigicon, Inc.K090663AMS SPECTRA CONCEALABLE PENILE PROSTHESISAmerican Medical Systems, Inc.K082006AMS SPECTRA CONCEALABLE PENILE PROSTHESISAmerican Medical Systems, Inc.K040959MENTOR GENESIS PENILE PROSTHESISMentor Corp.K963328AMS AMBICOR PENILE PROSTHESISAmerican Medical Systems, Inc.

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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