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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 K980066
Device Name CPR FILTERSHIELD
Applicant
Plasco, Inc.
4080 Morrison Dr.
Gurnee,  IL  60031
Applicant Contact GARY S BOTSFORD
Correspondent
Plasco, Inc.
4080 Morrison Dr.
Gurnee,  IL  60031
Correspondent Contact GARY S BOTSFORD
Regulation Number868.5915
Classification Product Code
BTM  
Date Received01/07/1998
Decision Date 07/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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