PNEUMATIC POWERED BUR— 510(k) K780139
Substantially EquivalentNorth Palm Beach Orthodepic Assoc.
FDA 510(k) clearance K780139 for PNEUMATIC POWERED BUR, Substantially Equivalent on 1978-02-01. Applicant: North Palm Beach Orthodepic Assoc.. Device class: 1.
Clearance details
- Applicant
- North Palm Beach Orthodepic Assoc.
- Product code
- Code HSZ
- Device class
- Class 1
- Regulation
- 21 CFR 878.4820
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code HSZ
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