AUTO SUTURE BONE WAX
FDA 510(k) clearance K971680 · decided 1997-10-24
Clearance details
- K-number
- K971680
- Device name
- AUTO SUTURE BONE WAX
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Decision
- Substantially Equivalent
- Date received
- 1997-05-07
- Decision date
- 1997-10-24
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- MTJ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Norwalk, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.