The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for R Pak.
| Device ID | K851203 |
| 510k Number | K851203 |
| Device Name: | R PAK |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | COOPERVISION, INC. 17701 COWAN AVE.P. O. BOX 19587 Irvine, CA 92713 |
| Contact | David W Krapp |
| Correspondent | David W Krapp COOPERVISION, INC. 17701 COWAN AVE.P. O. BOX 19587 Irvine, CA 92713 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-26 |
| Decision Date | 1985-07-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() R PAK 85052811 4126090 Dead/Cancelled |
RJR Polymers, Inc. 2010-06-02 |
![]() R PAK 75344315 2275296 Dead/Cancelled |
RJR POLYMERS, INC. 1997-08-18 |