The following data is part of a premarket notification filed by Surgin Surgical Instrumentation, Inc. with the FDA for Surgin Kit.
| Device ID | K980849 |
| 510k Number | K980849 |
| Device Name: | SURGIN KIT |
| Classification | Tubing, Replacement, Phacofragmentation Unit |
| 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 | MSR |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-05 |
| Decision Date | 1998-07-09 |