The following data is part of a premarket notification filed by Innovative Surgical Products Inc. with the FDA for Irrigation, Aspiration Tubing Sets.
| Device ID | K841072 |
| 510k Number | K841072 |
| Device Name: | IRRIGATION, ASPIRATION TUBING SETS |
| Classification | Unit, Phacofragmentation |
| Applicant | INNOVATIVE SURGICAL PRODUCTS INC. 1201 EAST WAKEHAM Santa Ana, CA 92705 |
| Contact | Duane Mason |
| Correspondent | Duane Mason INNOVATIVE SURGICAL PRODUCTS INC. 1201 EAST WAKEHAM Santa Ana, CA 92705 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-12 |
| Decision Date | 1984-03-29 |