NEOTRACT ANCHOR
FDA 510(k) clearance K061700 · decided 2006-10-26
Clearance details
- K-number
- K061700
- Device name
- NEOTRACT ANCHOR
- Applicant
- Neotract, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-06-16
- Decision date
- 2006-10-26
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- GAW
- Device class
- 2
- Regulation number
- 878.5010
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.