The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Paco-folder (tm) Intraocular Lens Forceps.
| Device ID | K864003 |
| 510k Number | K864003 |
| Device Name: | PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS |
| Classification | Forceps, Ophthalmic |
| Applicant | ALLERGAN, INC. POST OFFICE BOX 25155 Santa Ana, CA 92799 |
| Contact | Paul S Kramsky |
| Correspondent | Paul S Kramsky ALLERGAN, INC. POST OFFICE BOX 25155 Santa Ana, CA 92799 |
| Product Code | HNR |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-14 |
| Decision Date | 1986-10-31 |