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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, Manual (Resuscitator)
510(k) Number K874321
Device Name SOLCO SILICONE RESUSCITATOR
Applicant
Kahn-Tact U.S.A., Inc.
43 Yorkshire Woods
Oak Brook,  IL  60521
Applicant Contact GARY A KAHN
Correspondent
Kahn-Tact U.S.A., Inc.
43 Yorkshire Woods
Oak Brook,  IL  60521
Correspondent Contact GARY A KAHN
Regulation Number868.5915
Classification Product Code
BTM  
Date Received10/21/1987
Decision Date 01/19/1988
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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