The following data is part of a premarket notification filed by Precision-cosmet Co., Inc. with the FDA for Petrus Iol Guide.
Device ID | K840104 |
510k Number | K840104 |
Device Name: | PETRUS IOL GUIDE |
Classification | Lens, Guide, Intraocular |
Applicant | PRECISION-COSMET CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KYB |
CFR Regulation Number | 886.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-10 |
Decision Date | 1984-04-24 |