GME ExSys 308
FDA 510(k) clearance K150752 · decided 2015-07-31
Clearance details
- K-number
- K150752
- Device name
- GME ExSys 308
- Applicant
- Gme (German Medical Engineering) GmbH
- Decision
- Substantially Equivalent
- Date received
- 2015-03-23
- Decision date
- 2015-07-31
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- FTC
- Device class
- 2
- Regulation number
- 878.4630
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Nuerenberg, Bavaria, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.