The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for The Osteomed B Power System And Accessories.
| Device ID | K933101 |
| 510k Number | K933101 |
| Device Name: | THE OSTEOMED B POWER SYSTEM AND ACCESSORIES |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Applicant | OSTEOMED CORP. 3150 PREMIER DR. #110 Irving, TX 75063 |
| Contact | Rick Buss |
| Correspondent | Rick Buss OSTEOMED CORP. 3150 PREMIER DR. #110 Irving, TX 75063 |
| Product Code | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-24 |
| Decision Date | 1994-11-07 |