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 |