The following data is part of a premarket notification filed by Chesebrough-pond's U.s.a. Co. with the FDA for Chesebrough-pond's Reusable Urinary Leg.
Device ID | K842553 |
510k Number | K842553 |
Device Name: | CHESEBROUGH-POND'S REUSABLE URINARY LEG |
Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
Applicant | CHESEBROUGH-POND'S U.S.A. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNX |
CFR Regulation Number | 876.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-02 |
Decision Date | 1984-07-20 |