The following data is part of a premarket notification filed by Biolectron, Inc. with the FDA for Curvtek Tsr System.
| Device ID | K972860 |
| 510k Number | K972860 |
| Device Name: | CURVTEK TSR SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | BIOLECTRON, INC. 200 HOLT ST. Hackensack, NJ 07601 |
| Contact | Richard S Dugot |
| Correspondent | Richard S Dugot BIOLECTRON, INC. 200 HOLT ST. Hackensack, NJ 07601 |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-04 |
| Decision Date | 1997-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304408166 | K972860 | 000 |
| 00880304408142 | K972860 | 000 |
| 00880304408128 | K972860 | 000 |