The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Koi(tm) Instrument Trays.
| Device ID | K881095 |
| 510k Number | K881095 |
| Device Name: | KOI(TM) INSTRUMENT TRAYS |
| Classification | Tray, Surgical |
| Applicant | COOPERVISION, INC. COOPERVISION CILCO 3190 160TH AVENUE S.E. Bellevue, WA 98008 |
| Contact | Theresa N Corlett |
| Correspondent | Theresa N Corlett COOPERVISION, INC. COOPERVISION CILCO 3190 160TH AVENUE S.E. Bellevue, WA 98008 |
| Product Code | LRP |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-15 |
| Decision Date | 1988-04-06 |