HOLLISTER KARAYA SEAL RING

Collector, Ostomy

HOLLISTER, INC.

The following data is part of a premarket notification filed by Hollister, Inc. with the FDA for Hollister Karaya Seal Ring.

Pre-market Notification Details

Device IDK801503
510k NumberK801503
Device Name:HOLLISTER KARAYA SEAL RING
ClassificationCollector, Ostomy
Applicant HOLLISTER, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEXB  
CFR Regulation Number876.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-06-27
Decision Date1980-08-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.