The following data is part of a premarket notification filed by Atlantic Optical Systems, Inc. with the FDA for Universal Pack.
| Device ID | K831701 |
| 510k Number | K831701 |
| Device Name: | UNIVERSAL PACK |
| Classification | Unit, Phacofragmentation |
| Applicant | ATLANTIC OPTICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-25 |
| Decision Date | 1983-07-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() UNIVERSAL PACK 74052438 1632166 Dead/Cancelled |
DONATI, GINO 1990-04-24 |
![]() UNIVERSAL PACK 73669677 1478745 Dead/Cancelled |
VAUGHAN PRODUCTS, INC. 1987-07-01 |