NAVIGATOR (STYLET) 2006
FDA 510(k) clearance K972521 · decided 1997-10-01
Clearance details
- K-number
- K972521
- Device name
- NAVIGATOR (STYLET) 2006
- Applicant
- Sil-Med Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-07
- Decision date
- 1997-10-01
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- GAH
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Taunton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.