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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 K822116
Device Name ANESTHESIA BREATHING BAG, VARIOUS SIZES
Applicant
Life Design Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Life Design Systems, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5320
Classification Product Code
BTC  
Date Received07/19/1982
Decision Date 08/16/1982
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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