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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gown, surgical
510(k) Number K121664
Device Name T4/T5 HYTREL TOGAS
Original Applicant
4100 e. milham ave
kalamazoo,  MI  49001
Original Contact casey a metzger
Regulation Number878.4040
Classification Product Code
Date Received06/05/2012
Decision Date 03/10/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No