The following data is part of a premarket notification filed by Medtronic Navigation, Inc. with the FDA for Cranial Reducing Tubes.
| Device ID | K162604 |
| 510k Number | K162604 |
| Device Name: | Cranial Reducing Tubes |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Louisville, CO 80027 |
| Contact | Christopher Perman |
| Correspondent | Christopher Perman MEDTRONIC NAVIGATION, INC. 826 COAL CREEK CIRCLE Louisville, CO 80027 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-19 |
| Decision Date | 2016-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169969421 | K162604 | 000 |
| 00763000340308 | K162604 | 000 |
| 00763000340315 | K162604 | 000 |
| 00763000340322 | K162604 | 000 |
| 00643169909458 | K162604 | 000 |
| 00643169912991 | K162604 | 000 |
| 00643169913004 | K162604 | 000 |
| 00643169913011 | K162604 | 000 |
| 00643169966369 | K162604 | 000 |
| 00643169966376 | K162604 | 000 |
| 00643169966383 | K162604 | 000 |
| 00763000223021 | K162604 | 000 |