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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 K821309
Device Name ESPREE', BREATHING BAG
Applicant
ESP PLASTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ESP PLASTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5320
Classification Product Code
BTC  
Date Received05/04/1982
Decision Date 05/21/1982
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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