HEM-O-LOK -- MODIFICATION
FDA 510(k) clearance K922186 · decided 1992-08-06
Clearance details
- K-number
- K922186
- Device name
- HEM-O-LOK -- MODIFICATION
- Applicant
- Linvatec Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-02-27
- Decision date
- 1992-08-06
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- GDW
- Device class
- 2
- Regulation number
- 878.4750
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Research Triangle Pa, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.