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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bag, Reservoir
510(k) Number K841412
Device Name ROLLED NECK W/TAP
Applicant
Warne Surgical Products, Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Warne Surgical Products, Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5320
Classification Product Code
BTC  
Date Received04/05/1984
Decision Date 04/18/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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