NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX
FDA 510(k) clearance K101080 · decided 2010-06-21
Clearance details
- K-number
- K101080
- Device name
- NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX
- Applicant
- Egon Faulhaber Surgical Instruments Pinzetten
- Decision
- Substantially Equivalent
- Date received
- 2010-04-19
- Decision date
- 2010-06-21
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Wurmlingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.