The following data is part of a premarket notification filed by Applied Laboratories, Inc. with the FDA for Mobay (bayer) Makrolon 2658 1112.
| Device ID | K873820 |
| 510k Number | K873820 |
| Device Name: | MOBAY (BAYER) MAKROLON 2658 1112 |
| Classification | Case, Contact Lens |
| Applicant | APPLIED LABORATORIES, INC. 3360 COMMERCE PARK DR. Columbus, IN 47201 |
| Contact | Anthony J Moravec |
| Correspondent | Anthony J Moravec APPLIED LABORATORIES, INC. 3360 COMMERCE PARK DR. Columbus, IN 47201 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-21 |
| Decision Date | 1988-03-24 |