The following data is part of a premarket notification filed by Surgical Dynamics, Inc. with the FDA for Nucleotome 3.5 Mm Automated Percutaneous Lumbar.
| Device ID | K923525 |
| 510k Number | K923525 |
| Device Name: | NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR |
| Classification | Arthroscope |
| Applicant | SURGICAL DYNAMICS, INC. 1240 SOUTH LOOP RD. Alameda, CA 94501 |
| Contact | Charmaine Henderson |
| Correspondent | Charmaine Henderson SURGICAL DYNAMICS, INC. 1240 SOUTH LOOP RD. Alameda, CA 94501 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-16 |
| Decision Date | 1993-02-09 |