The following data is part of a premarket notification filed by Atlantic Optical Systems, Inc. with the FDA for Atlantic Optical Systems, Inc. Universal Pack.
| Device ID | K850532 |
| 510k Number | K850532 |
| Device Name: | ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK |
| Classification | Unit, Phacofragmentation |
| Applicant | ATLANTIC OPTICAL SYSTEMS, INC. P.O. BOX 510 Leechburg, PA 15656 |
| Contact | William J Boyle |
| Correspondent | William J Boyle ATLANTIC OPTICAL SYSTEMS, INC. P.O. BOX 510 Leechburg, PA 15656 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-11 |
| Decision Date | 1985-04-15 |