The following data is part of a premarket notification filed by Surgical Instrument, Inc. with the FDA for Ophthalmic Cannula.
Device ID | K881487 |
510k Number | K881487 |
Device Name: | OPHTHALMIC CANNULA |
Classification | Cannula, Ophthalmic |
Applicant | SURGICAL INSTRUMENT, INC. 1030 RICHFIELD RD. Placentia, CA 92670 |
Contact | Stephen M Priolo |
Correspondent | Stephen M Priolo SURGICAL INSTRUMENT, INC. 1030 RICHFIELD RD. Placentia, CA 92670 |
Product Code | HMX |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-08 |
Decision Date | 1988-04-29 |