THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
FDA 510(k) clearance K132645 · decided 2013-10-04
Clearance details
- K-number
- K132645
- Device name
- THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-08-23
- Decision date
- 2013-10-04
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- GAD
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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| RETRACTOR (K941448) | Technovations | 1994-04-15 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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