OPER-FILM-ADHESIVE MEMBRANE— 510(k) K881936

Substantially Equivalent for Some Indications

Iberhospitex, S.A.

FDA 510(k) clearance K881936 for OPER-FILM-ADHESIVE MEMBRANE, Substantially Equivalent for Some Indications on 1988-08-31. Applicant: Iberhospitex, S.A..

Clearance details

Applicant: Iberhospitex, S.A.
Product code: Code NAD
Advisory panel: General, Plastic Surgery
Date received: 1988-05-09
Decision date: 1988-08-31
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Barcelona, Spain, ES

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Adverse events under product code NAD

product code NAD

Injury: 431
Malfunction: 11,935
Other: 1
Total: 12,367

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.