APOLLO STERILE BLADES— 510(k) K852661
Substantially EquivalentOrthofab, Inc.
FDA 510(k) clearance K852661 for APOLLO STERILE BLADES, Substantially Equivalent on 1985-07-11. Applicant: Orthofab, Inc.. Device class: 1.
Clearance details
- Applicant
- Orthofab, Inc.
- Product code
- Code GES
- 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
- Cottage Grove, MN, US
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