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FDA 510(k)

DERMICEL, MONTGOMERY STRAP

K-Number: K882696 · 1988-08-26

ApplicantBioseal
Decision Date1988-08-26
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMICEL, MONTGOMERY STRAP is the device name listed in this FDA 510(k) record. The listed applicant is Bioseal. It received FDA 510(k) clearance on 1988-08-26 under 510(k) number K882696. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMICEL, MONTGOMERY STRAP?

DERMICEL, MONTGOMERY STRAP is a medical device that received FDA 510(k) clearance on 1988-08-26. The listed applicant is Bioseal. The 510(k) number is K882696.

When did DERMICEL, MONTGOMERY STRAP receive FDA 510(k) clearance?

DERMICEL, MONTGOMERY STRAP received FDA 510(k) clearance on 1988-08-26, under 510(k) number K882696.

Who is the listed applicant for DERMICEL, MONTGOMERY STRAP?

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

What is the FDA product code for DERMICEL, MONTGOMERY STRAP?

The FDA product code for DERMICEL, MONTGOMERY STRAP is NAD.

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Other records listing Bioseal 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.

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Related Devices (Code: NAD)

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.

K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.K102403SAM CHEST SEAL WITH VAVLE; SAM CHEST SEALSam Medical ProductsK091133APLION TOPICAL CARE SYSTEMAplion Medical,LlcK072560ENVELA (HYDROHESIVE OCCLUSIVE DRESSING)Teikoku Pharma USA, Inc.K080524CENTURION SORBAVIEW OTCTri-State Hospital Supply Corp.K060046DERMASTREAMEnzysurge , Ltd.

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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