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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 K880680
Device Name KING SYSTEMS, BREATHING BAG
Applicant
King Systems Corp.
15011 Herriman Blvd.
P.O. Box 1138
Noblesville,  IN  46060
Applicant Contact LINDA L NORDLUND
Correspondent
King Systems Corp.
15011 Herriman Blvd.
P.O. Box 1138
Noblesville,  IN  46060
Correspondent Contact LINDA L NORDLUND
Regulation Number868.5320
Classification Product Code
BTC  
Date Received02/19/1988
Decision Date 03/03/1988
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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