The following data is part of a premarket notification filed by Magnivision, Inc. with the FDA for Soft Contact Lens Remover.
Device ID | K872567 |
510k Number | K872567 |
Device Name: | SOFT CONTACT LENS REMOVER |
Classification | Inserter/remover Contact Lens |
Applicant | MAGNIVISION, INC. P.O. BOX 817 Miami, FL 33152 |
Contact | Steve Felkowitz |
Correspondent | Steve Felkowitz MAGNIVISION, INC. P.O. BOX 817 Miami, FL 33152 |
Product Code | KYE |
CFR Regulation Number | 886.5420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-29 |
Decision Date | 1987-08-10 |