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FDA 510(k)

COMFEEL PLUS PRESSURE RELIEF DRESSING

K-Number: K951325 · 1995-07-31

ApplicantRichard Hamer Assoc., Inc.
Decision Date1995-07-31
Product CodeFMP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMFEEL PLUS PRESSURE RELIEF DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Richard Hamer Assoc., Inc.. It received FDA 510(k) clearance on 1995-07-31 under 510(k) number K951325. 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 COMFEEL PLUS PRESSURE RELIEF DRESSING?

COMFEEL PLUS PRESSURE RELIEF DRESSING is a medical device that received FDA 510(k) clearance on 1995-07-31. The listed applicant is Richard Hamer Assoc., Inc.. The 510(k) number is K951325.

When did COMFEEL PLUS PRESSURE RELIEF DRESSING receive FDA 510(k) clearance?

COMFEEL PLUS PRESSURE RELIEF DRESSING received FDA 510(k) clearance on 1995-07-31, under 510(k) number K951325.

Who is the listed applicant for COMFEEL PLUS PRESSURE RELIEF DRESSING?

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

What is the FDA product code for COMFEEL PLUS PRESSURE RELIEF DRESSING?

The FDA product code for COMFEEL PLUS PRESSURE RELIEF DRESSING 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Richard Hamer Assoc., 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.

K962439DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)K950934MPM HYDROGEL DRESSINGK951327COMFEEL PLUS CONTOUR DRESSINGK942283COMFEEL PLUS TRANSPARENT DRESSINGK942573COSTELLO-EVERETT LASER CYSTOSCOPE SHEATHK941263COMFEEL PLUS WOUND DRESSING

View all 8 devices →

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.

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.K802185ARTERIAL BLOOD SAMPLING KITCurrent Technologies, Inc.

Official Source

View on FDA Database →

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

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