DISPOSABLE EXTERNAL CLAMPS— 510(k) K896383
Substantially EquivalentGalenica Enterprises, Inc.
FDA 510(k) clearance K896383 for DISPOSABLE EXTERNAL CLAMPS, Substantially Equivalent on 1989-12-06. Applicant: Galenica Enterprises, Inc.. Device class: 1.
Clearance details
- Applicant
- Galenica Enterprises, Inc.
- Product code
- Code GDI
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Quebec Canada J7e 4h7, CA
Recent devices under product code GDI
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