The following data is part of a premarket notification filed by Atlantic Optical Systems, Inc. with the FDA for Universal Pack.
| Device ID | K834155 |
| 510k Number | K834155 |
| Device Name: | UNIVERSAL PACK |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | ATLANTIC OPTICAL SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-02 |
| Decision Date | 1984-06-19 |
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 |