TAN MODEL I
FDA 510(k) clearance K853046 · decided 1985-08-07
Clearance details
- K-number
- K853046
- Device name
- TAN MODEL I
- Applicant
- Philip Munsterman Tan, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-07-19
- Decision date
- 1985-08-07
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- FTC
- Device class
- 2
- Regulation number
- 878.4630
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Jacksonville, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.