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FDA 510(k)

OPER-FILM-ADHESIVE MEMBRANE

K-Number: K881936 · 1988-08-31

ApplicantIberhospitex, S.A.
Decision Date1988-08-31
Product CodeNAD
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

OPER-FILM-ADHESIVE MEMBRANE is the device name listed in this FDA 510(k) record. The listed applicant is Iberhospitex, S.A.. It received FDA 510(k) clearance on 1988-08-31 under 510(k) number K881936. The device is classified under product code NAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the OPER-FILM-ADHESIVE MEMBRANE?

OPER-FILM-ADHESIVE MEMBRANE is a medical device that received FDA 510(k) clearance on 1988-08-31. The listed applicant is Iberhospitex, S.A.. The 510(k) number is K881936.

When did OPER-FILM-ADHESIVE MEMBRANE receive FDA 510(k) clearance?

OPER-FILM-ADHESIVE MEMBRANE received FDA 510(k) clearance on 1988-08-31, under 510(k) number K881936.

Who is the listed applicant for OPER-FILM-ADHESIVE MEMBRANE?

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

What is the FDA product code for OPER-FILM-ADHESIVE MEMBRANE?

The FDA product code for OPER-FILM-ADHESIVE MEMBRANE is NAD.

Related Clinical Trials

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Other records listing Iberhospitex, S.A. 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.

K883982DRENOVACK883983SANIFIX

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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