The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Thoratrak Mics Retractor System, Rack, Blades.
| Device ID | K132645 |
| 510k Number | K132645 |
| Device Name: | THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES |
| Classification | Retractor |
| Applicant | MEDTRONIC, INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Chelsea Pioske |
| Correspondent | Chelsea Pioske MEDTRONIC, INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-23 |
| Decision Date | 2013-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169615410 | K132645 | 000 |
| 00643169615403 | K132645 | 000 |
| 00643169615397 | K132645 | 000 |
| 00643169615380 | K132645 | 000 |
| 00643169615373 | K132645 | 000 |
| 00643169615366 | K132645 | 000 |
| 00643169615359 | K132645 | 000 |
| 00643169615342 | K132645 | 000 |
| 00643169615335 | K132645 | 000 |