The following data is part of a premarket notification filed by Atlantic Optical Systems, Inc. with the FDA for Atlantic Optical Systems Optifilter System.
| Device ID | K850533 |
| 510k Number | K850533 |
| Device Name: | ATLANTIC OPTICAL SYSTEMS OPTIFILTER SYSTEM |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-11 |
| Decision Date | 1985-03-21 |