The following data is part of a premarket notification filed by D & D Surgical with the FDA for Iol Implantation Forceps.
Device ID | K883197 |
510k Number | K883197 |
Device Name: | IOL IMPLANTATION FORCEPS |
Classification | Forceps, Ophthalmic |
Applicant | D & D SURGICAL 6210 LAKE WASHINGTON BLVD. SE. Renton, WA 98056 |
Contact | Vaclav Dusek |
Correspondent | Vaclav Dusek D & D SURGICAL 6210 LAKE WASHINGTON BLVD. SE. Renton, WA 98056 |
Product Code | HNR |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-28 |
Decision Date | 1988-08-22 |