DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER— 510(k) K082208

Substantially Equivalent

Scivolutions, Inc.

FDA 510(k) clearance K082208 for DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER, Substantially Equivalent on 2008-12-01. Applicant: Scivolutions, Inc..

Clearance details

Applicant: Scivolutions, Inc.
Product code: Code NAC
Advisory panel: General, Plastic Surgery
Date received: 2008-08-05
Decision date: 2008-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, US

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Adverse events under product code NAC

product code NAC

Malfunction: 475
Total: 475

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.