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FDA 510(k)

C3 EXTERNAL MALE BLADDER CONTROL DEVICE

K-Number: K974040 · 1998-07-14

ApplicantTimm Research Co.
Decision Date1998-07-14
Product CodeFHA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

C3 EXTERNAL MALE BLADDER CONTROL DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Timm Research Co.. It received FDA 510(k) clearance on 1998-07-14 under 510(k) number K974040. The device is classified under product code FHA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C3 EXTERNAL MALE BLADDER CONTROL DEVICE?

C3 EXTERNAL MALE BLADDER CONTROL DEVICE is a medical device that received FDA 510(k) clearance on 1998-07-14. The listed applicant is Timm Research Co.. The 510(k) number is K974040.

When did C3 EXTERNAL MALE BLADDER CONTROL DEVICE receive FDA 510(k) clearance?

C3 EXTERNAL MALE BLADDER CONTROL DEVICE received FDA 510(k) clearance on 1998-07-14, under 510(k) number K974040.

Who is the listed applicant for C3 EXTERNAL MALE BLADDER CONTROL DEVICE?

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

What is the FDA product code for C3 EXTERNAL MALE BLADDER CONTROL DEVICE?

The FDA product code for C3 EXTERNAL MALE BLADDER CONTROL DEVICE is FHA.

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Related Devices (Code: FHA)

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.

K971992UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)Uromed Corp.K970308MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCEMentor Urology, Inc.K964580CAP-AID (IMPROVED)Nebel, Inc.K955810U-TEXLaborie Medical Technologies, Ltd.K954959CAP-AIDNebl, Inc.K952841THE ASSISTANTApple Medical Corp.

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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