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FDA 510(k)

FOAM COMFORT RINGS

K-Number: K781246 · 1978-08-10

ApplicantFibre Formations, Inc.
Decision Date1978-08-10
Product CodeFMP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FOAM COMFORT RINGS is the device name listed in this FDA 510(k) record. The listed applicant is Fibre Formations, Inc.. It received FDA 510(k) clearance on 1978-08-10 under 510(k) number K781246. The device is classified under product code FMP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOAM COMFORT RINGS?

FOAM COMFORT RINGS is a medical device that received FDA 510(k) clearance on 1978-08-10. The listed applicant is Fibre Formations, Inc.. The 510(k) number is K781246.

When did FOAM COMFORT RINGS receive FDA 510(k) clearance?

FOAM COMFORT RINGS received FDA 510(k) clearance on 1978-08-10, under 510(k) number K781246.

Who is the listed applicant for FOAM COMFORT RINGS?

The FDA 510(k) record lists Fibre Formations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOAM COMFORT RINGS?

The FDA product code for FOAM COMFORT RINGS is FMP.

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 Fibre Formations, Inc. 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.

K791709HEEL/ELBOW PROTECTORSK790922DISPOSABLE ADULT DIAPERK781930PANT LINER, DISP. INCONTINENTK781233IV ARMBOARDS

Related Devices (Code: FMP)

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.

K951325COMFEEL PLUS PRESSURE RELIEF DRESSINGRichard Hamer Assoc., Inc.K934731MEDSURG STERILE IMAGING PRODUCTSMedsurg Industries, Inc.K820584DECUBICARE PADS & ACCESSORIESAbco Dealers, Inc.K812344HEEL OR ELBOW PROTECTORFred Sammons, Inc.K811184SPENCO DERMAL PADSSpenco Medical Corp.K802829SCANLAN VASCU-STATTScanlan Intl., 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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