CRYOMINI
FDA 510(k) clearance K080735 · decided 2008-04-04
Clearance details
- K-number
- K080735
- Device name
- CRYOMINI
- Applicant
- Zimmer Elektromedizin GmbH
- Decision
- Substantially Equivalent
- Date received
- 2008-03-17
- Decision date
- 2008-04-04
- Days to decision
- 18 days
- Clearance type
- Special
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Neu-Elm, DE
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.