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FDA 510(k)

COMFEEL PLUS TRANSPARENT DRESSING

K-Number: K942283 · 1994-07-29

ApplicantRichard Hamer Assoc., Inc.
Decision Date1994-07-29
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

COMFEEL PLUS TRANSPARENT 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 1994-07-29 under 510(k) number K942283. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the COMFEEL PLUS TRANSPARENT DRESSING?

COMFEEL PLUS TRANSPARENT DRESSING is a medical device that received FDA 510(k) clearance on 1994-07-29. The listed applicant is Richard Hamer Assoc., Inc.. The 510(k) number is K942283.

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

COMFEEL PLUS TRANSPARENT DRESSING received FDA 510(k) clearance on 1994-07-29, under 510(k) number K942283.

Who is the listed applicant for COMFEEL PLUS TRANSPARENT 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 TRANSPARENT DRESSING?

The FDA product code for COMFEEL PLUS TRANSPARENT DRESSING is KMF.

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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)K951325COMFEEL PLUS PRESSURE RELIEF DRESSINGK950934MPM HYDROGEL DRESSINGK951327COMFEEL PLUS CONTOUR DRESSINGK942573COSTELLO-EVERETT LASER CYSTOSCOPE SHEATHK941263COMFEEL PLUS WOUND DRESSING

View all 8 devices →

Related Devices (Code: KMF)

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.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, 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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