The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Incare Intermittent Catheter.
Device ID | K013345 |
510k Number | K013345 |
Device Name: | INCARE INTERMITTENT CATHETER |
Classification | Catheter, Urological |
Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
Contact | Joseph S Tokarz |
Correspondent | Joseph S Tokarz HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
Product Code | KOD |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-10-09 |
Decision Date | 2002-01-07 |
Summary: | summary |