The following data is part of a premarket notification filed by Surgical Dynamics, Inc. with the FDA for Nucleotome L Kit.
| Device ID | K942987 |
| 510k Number | K942987 |
| Device Name: | NUCLEOTOME L KIT |
| Classification | Motor, Surgical Instrument, Pneumatic Powered |
| Applicant | SURGICAL DYNAMICS, INC. 2575 STANWELL DR. Concord, CA 94520 |
| Contact | Charmaine Henderson |
| Correspondent | Charmaine Henderson SURGICAL DYNAMICS, INC. 2575 STANWELL DR. Concord, CA 94520 |
| Product Code | GET |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-20 |
| Decision Date | 1995-10-30 |