OTOSILK OTOLOGICAL GRAFT DRESSING— 510(k) K964534

Substantially Equivalent

Boston Medical Products, Inc.

FDA 510(k) clearance K964534 for OTOSILK OTOLOGICAL GRAFT DRESSING, Substantially Equivalent on 1997-04-09. Applicant: Boston Medical Products, Inc..

Clearance details

Applicant: Boston Medical Products, Inc.
Product code: Code NAD
Advisory panel: General, Plastic Surgery
Date received: 1996-11-12
Decision date: 1997-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westborough, MA, US

Download summary PDF View on FDA.gov ↗

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.