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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 K894906
Device Name ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER
Applicant
MED-TEK CORP.
6685 NORTH SIDNEY PLACE
GLENDALE,  WI  53209
Applicant Contact ALAN E WHITMARSH
Correspondent
MED-TEK CORP.
6685 NORTH SIDNEY PLACE
GLENDALE,  WI  53209
Correspondent Contact ALAN E WHITMARSH
Regulation Number868.5320
Classification Product Code
BTC  
Date Received08/01/1989
Decision Date 09/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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