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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Gas-Scavenging
510(k) Number K770344
Device Name SH-1
Applicant
Delta Medical Industries
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Delta Medical Industries
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5430
Classification Product Code
CBN  
Date Received02/18/1977
Decision Date 05/09/1977
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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