The following data is part of a premarket notification filed by Medical Instrument Development Laboratories, Inc. with the FDA for Infusion Sleeve - Ophthalmic.
Device ID | K851009 |
510k Number | K851009 |
Device Name: | INFUSION SLEEVE - OPHTHALMIC |
Classification | Unit, Phacofragmentation |
Applicant | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 2235 POLVOROSA AVE. SUITE 200 San Leandro, CA 94577 |
Contact | William T George |
Correspondent | William T George MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 2235 POLVOROSA AVE. SUITE 200 San Leandro, CA 94577 |
Product Code | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-12 |
Decision Date | 1985-04-03 |