The following data is part of a premarket notification filed by Surgical Dynamics, Inc. with the FDA for Nucleotome(r) Ii (version2) Tissue Aspira/cutter.
| Device ID | K914282 |
| 510k Number | K914282 |
| Device Name: | NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER |
| Classification | Arthroscope |
| Applicant | SURGICAL DYNAMICS, INC. 1240 SOUTH LOOP RD. Alameda, CA 94501 |
| Contact | Brad Hutting |
| Correspondent | Brad Hutting 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 | 1991-09-24 |
| Decision Date | 1991-12-19 |