The following data is part of a premarket notification filed by Advanced Medical Technology, Inc. with the FDA for Allergan I.s.p. Model 3000 Ophthalmic Surgical-sys.
| Device ID | K854225 |
| 510k Number | K854225 |
| Device Name: | ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS |
| Classification | Unit, Phacofragmentation |
| Applicant | ADVANCED MEDICAL TECHNOLOGY, INC. WESTHAVEN BLDGL - SUITE 201 15751 BROOKHURST STREET Westminister, CA 92683 |
| Contact | Thomas V Keeley |
| Correspondent | Thomas V Keeley ADVANCED MEDICAL TECHNOLOGY, INC. WESTHAVEN BLDGL - SUITE 201 15751 BROOKHURST STREET Westminister, CA 92683 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-18 |
| Decision Date | 1985-12-27 |