HTR POLYMER, HTR-MX
FDA 510(k) clearance K904111 · decided 1990-11-23
Clearance details
- K-number
- K904111
- Device name
- HTR POLYMER, HTR-MX
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Decision
- Substantially Equivalent
- Date received
- 1990-09-06
- Decision date
- 1990-11-23
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- KKY
- Device class
- 2
- Regulation number
- 878.3500
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- 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.