The following data is part of a premarket notification filed by Magnivision, Inc. with the FDA for Comfees(r) + Con-pak(tm) Lens Case.
| Device ID | K897085 |
| 510k Number | K897085 |
| Device Name: | COMFEES(R) + CON-PAK(TM) LENS CASE |
| Classification | Case, Contact Lens |
| Applicant | MAGNIVISION, INC. 5325 N.W. 77TH AVE. Miami, FL 33166 |
| Contact | Roy Hirschfeld |
| Correspondent | Roy Hirschfeld MAGNIVISION, INC. 5325 N.W. 77TH AVE. Miami, FL 33166 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-20 |
| Decision Date | 1990-02-28 |