The following data is part of a premarket notification filed by Surgin Surgical Instrumentation, Inc. with the FDA for 10-0 Cassette.
| Device ID | K942516 |
| 510k Number | K942516 |
| Device Name: | 10-0 CASSETTE |
| Classification | Unit, Phacofragmentation |
| Applicant | SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin, CA 92680 |
| Contact | Don Haar |
| Correspondent | Don Haar SURGIN SURGICAL INSTRUMENTATION, INC. 14762 BENTLEY CIRCLE Tustin, CA 92680 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-26 |
| Decision Date | 1994-07-25 |