The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Complete Brand Lubricating And Rewetting Drops.
| Device ID | K983150 |
| 510k Number | K983150 |
| Device Name: | COMPLETE BRAND LUBRICATING AND REWETTING DROPS |
| Classification | Accessories, Soft Lens Products |
| Applicant | ALLERGAN, INC. 2525 DUPONT DR. P.O. BOX 19534 Irvine, CA 92623 -9534 |
| Contact | Paul J Nowacki |
| Correspondent | Paul J Nowacki ALLERGAN, INC. 2525 DUPONT DR. P.O. BOX 19534 Irvine, CA 92623 -9534 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-09 |
| Decision Date | 1998-11-25 |
| Summary: | summary |