The following data is part of a premarket notification filed by Dmv Contact Lens Co. with the FDA for Soft Lens Remover/inserter/manipulator.
Device ID | K780664 |
510k Number | K780664 |
Device Name: | SOFT LENS REMOVER/INSERTER/MANIPULATOR |
Classification | Inserter/remover Contact Lens |
Applicant | DMV CONTACT LENS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KYE |
CFR Regulation Number | 886.5420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-04-20 |
Decision Date | 1978-05-17 |