BODY-JET
FDA 510(k) clearance K082025 · decided 2008-08-13
Clearance details
- K-number
- K082025
- Device name
- BODY-JET
- Applicant
- Human Med AG
- Decision
- Substantially Equivalent
- Date received
- 2008-07-17
- Decision date
- 2008-08-13
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- QPB
- Device class
- 2
- Regulation number
- 878.5040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Schwerin, DE
- Third-party review
- Yes
- Expedited review
- No
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