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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 K932584
Device Name BREATHING BAGS
Applicant
MERIT MEDICAL SYSTEMS, INC.
8102 WOODLAND DR/.
INDIANAPOLIS,  IN  46278
Applicant Contact ROBERT RICHMOND
Correspondent
MERIT MEDICAL SYSTEMS, INC.
8102 WOODLAND DR/.
INDIANAPOLIS,  IN  46278
Correspondent Contact ROBERT RICHMOND
Regulation Number868.5320
Classification Product Code
BTC  
Date Received05/27/1993
Decision Date 07/16/1993
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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