The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Amo Phacoflex Ii Intersection System.
| Device ID | K961242 |
| 510k Number | K961242 |
| Device Name: | AMO PHACOFLEX II INTERSECTION SYSTEM |
| Classification | Lens, Guide, Intraocular |
| Applicant | ALLERGAN, INC. 2525 DUPONT DR. Irvine, CA 92612 |
| Contact | Maureen Weiner |
| Correspondent | Maureen Weiner ALLERGAN, INC. 2525 DUPONT DR. Irvine, CA 92612 |
| Product Code | KYB |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-01 |
| Decision Date | 1996-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15050474534466 | K961242 | 000 |
| 15050474530031 | K961242 | 000 |
| 15050474530024 | K961242 | 000 |
| 15050474534503 | K961242 | 000 |
| 15050474523491 | K961242 | 000 |
| 15050474500126 | K961242 | 000 |