The following data is part of a premarket notification filed by Waters Assoc., Inc. with the FDA for Pab Convenience Tray.
Device ID | K781264 |
510k Number | K781264 |
Device Name: | PAB CONVENIENCE TRAY |
Classification | Needle, Aspiration And Injection, Disposable |
Applicant | WATERS ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GAA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-07-24 |
Decision Date | 1978-09-20 |