The following data is part of a premarket notification filed by Design Research Assoc., Inc. with the FDA for Nld Implant Set.
Device ID | K813314 |
510k Number | K813314 |
Device Name: | NLD IMPLANT SET |
Classification | Cannula, Ophthalmic |
Applicant | DESIGN RESEARCH ASSOC., INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | HMX |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-24 |
Decision Date | 1982-02-24 |