The following data is part of a premarket notification filed by Surgin Surgical Instrumentation, Inc. with the FDA for Surgi-wipe.
| Device ID | K942642 |
| 510k Number | K942642 |
| Device Name: | SURGI-WIPE |
| Classification | Sponge, Ophthalmic |
| 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 | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-03 |
| Decision Date | 1994-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10852171007824 | K942642 | 000 |
| 10852171007718 | K942642 | 000 |
| 10852171007725 | K942642 | 000 |
| 10852171007732 | K942642 | 000 |
| 10852171007749 | K942642 | 000 |
| 10852171007756 | K942642 | 000 |
| 10852171007763 | K942642 | 000 |
| 10852171007770 | K942642 | 000 |
| 10852171007787 | K942642 | 000 |
| 10852171007794 | K942642 | 000 |
| 10852171007800 | K942642 | 000 |
| 10852171007817 | K942642 | 000 |
| 10852171007701 | K942642 | 000 |