The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Hollister Premium Urine Collector.
Device ID | K931277 |
510k Number | K931277 |
Device Name: | HOLLISTER PREMIUM URINE COLLECTOR |
Classification | Device, Paste-on For Incontinence, Sterile |
Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
Contact | Joseph Tokarz |
Correspondent | Joseph Tokarz HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
Product Code | EXI |
CFR Regulation Number | 876.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-08 |
Decision Date | 1993-06-23 |