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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bottle, Collection And Trap, Breathing System (Uncalibrated)
510(k) Number K760082
Device Name BOTTLE, CONDENSATE (#1628)
Applicant
Inspiron Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Inspiron Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6740
Classification Product Code
CBC  
Date Received06/21/1976
Decision Date 07/16/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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