TR-100
FDA 510(k) clearance K161551 · decided 2016-09-13
Clearance details
- K-number
- K161551
- Device name
- TR-100
- Applicant
- BTL Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-06-03
- Decision date
- 2016-09-13
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- PBX
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Framingham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.