The following data is part of a premarket notification filed by Micron Surgical, Inc. with the FDA for Weiss Retinal Cannula.
Device ID | K010305 |
510k Number | K010305 |
Device Name: | WEISS RETINAL CANNULA |
Classification | Cannula, Ophthalmic |
Applicant | MICRON SURGICAL, INC. 5800 COLONIAL DR. SUITE 300 Margate, FL 33063 |
Contact | April Dean |
Correspondent | April Dean MICRON SURGICAL, INC. 5800 COLONIAL DR. SUITE 300 Margate, FL 33063 |
Product Code | HMX |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-02-01 |
Decision Date | 2001-05-02 |