The following data is part of a premarket notification filed by Surgical Dynamics, Inc. with the FDA for Surgical Dynamics Nucleotome Ii Tissue Aspir/cuter.
| Device ID | K902778 |
| 510k Number | K902778 |
| Device Name: | SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER |
| Classification | Arthroscope |
| Applicant | SURGICAL DYNAMICS, INC. CHARLES I. ROSE & CO., INC. 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose SURGICAL DYNAMICS, INC. CHARLES I. ROSE & CO., INC. 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-25 |
| Decision Date | 1990-10-30 |