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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tent, Oxygen, Electrically Powered
510(k) Number K941547
Device Name CAM 4 THERMOELECTRIC CHILD/ADULT MIST TENT
Applicant
Allied Healthcare Products, Inc.
1720 Sublette Ave.
Saint Louis,  MO  63110
Applicant Contact WAYNE KARCHER
Correspondent
Allied Healthcare Products, Inc.
1720 Sublette Ave.
Saint Louis,  MO  63110
Correspondent Contact WAYNE KARCHER
Regulation Number868.5710
Classification Product Code
BYK  
Date Received03/30/1994
Decision Date 03/01/1995
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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