HAND STC, MODEL 60MM
FDA 510(k) clearance K042492 · decided 2004-10-19
Clearance details
- K-number
- K042492
- Device name
- HAND STC, MODEL 60MM
- Applicant
- Niti Medical Technologies , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-14
- Decision date
- 2004-10-19
- Days to decision
- 35 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
- Netanya, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.