The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Instaflo Bowel Catheter System Kit.
Device ID | K100273 |
510k Number | K100273 |
Device Name: | INSTAFLO BOWEL CATHETER SYSTEM KIT |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
Contact | Benjamin Lichtenwalner |
Correspondent | Benjamin Lichtenwalner HOLLISTER, INC. 2000 HOLLISTER DR. Libertyville, IL 60048 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-01-29 |
Decision Date | 2010-04-22 |
Summary: | summary |