EXTERNAL BREAST PROSTHESIS— 510(k) K813416

Substantially Equivalent

Surgical Appliance Industries, Inc.

FDA 510(k) clearance K813416 for EXTERNAL BREAST PROSTHESIS, Substantially Equivalent on 1982-01-18. Applicant: Surgical Appliance Industries, Inc..

Clearance details

Applicant
Surgical Appliance Industries, Inc.
Product code
Code GBI
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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