The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Navipro Shoulder Software Module.
| Device ID | K050897 |
| 510k Number | K050897 |
| Device Name: | NAVIPRO SHOULDER SOFTWARE MODULE |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | KINAMED, INC. 820 FLYNN RD. Camarillo, CA 93012 |
| Contact | Vineet K Sarin |
| Correspondent | Vineet K Sarin KINAMED, INC. 820 FLYNN RD. Camarillo, CA 93012 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-08 |
| Decision Date | 2005-05-24 |
| Summary: | summary |