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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K860077
Device Name SG-066 OXYGEN ENRICHMENT KIT
Applicant
Instrumentation Industries, Inc.
2990 Industrial Blvd.
Bethel Park,  PA  15102
Applicant Contact CLYDE T MARRANGONI
Correspondent
Instrumentation Industries, Inc.
2990 Industrial Blvd.
Bethel Park,  PA  15102
Correspondent Contact CLYDE T MARRANGONI
Regulation Number868.5925
Classification Product Code
BTL  
Date Received01/08/1986
Decision Date 02/18/1986
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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