HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES
FDA 510(k) clearance K183009 · decided 2018-11-26
Clearance details
- K-number
- K183009
- Device name
- HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES
- Applicant
- Hemostatix Medical Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-10-31
- Decision date
- 2018-11-26
- Days to decision
- 26 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bartlett, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.