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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K770392
Device Name MUFFLER, AIR PUMP
Applicant
CUTTER LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CUTTER LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5260
Classification Product Code
CAH  
Date Received02/28/1977
Decision Date 03/07/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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