The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteopower System And Accessories.
| Device ID | K971692 |
| 510k Number | K971692 |
| Device Name: | OSTEOPOWER SYSTEM AND ACCESSORIES |
| Classification | Handpiece, Rotary Bone Cutting |
| Applicant | OSTEOMED CORP. 3150 PREMIER DR. #110 Irving, TX 75063 |
| Contact | Cindy Walters |
| Correspondent | Cindy Walters OSTEOMED CORP. 3150 PREMIER DR. #110 Irving, TX 75063 |
| Product Code | KMW |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-07 |
| Decision Date | 1997-06-27 |