The following data is part of a premarket notification filed by Surgeon Surgical Instrumentation, Inc. with the FDA for Multi-spike.
| Device ID | K861203 |
| 510k Number | K861203 |
| Device Name: | MULTI-SPIKE |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | SURGEON SURGICAL INSTRUMENTATION, INC. 1061 N. SHEPARD ST. SUITE C Anaheim, CA 92806 |
| Contact | Armand Maaskamp |
| Correspondent | Armand Maaskamp SURGEON SURGICAL INSTRUMENTATION, INC. 1061 N. SHEPARD ST. SUITE C Anaheim, CA 92806 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-01 |
| Decision Date | 1986-04-28 |