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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 K930429
Device Name AID, CARDIOPULMONARY RESUSCITATION
Applicant
Valley Forge Scientific Corp.
P.O. Box 925
Valley Forge,  PA  19482
Applicant Contact THOMAS J GILLOWAY
Correspondent
Valley Forge Scientific Corp.
P.O. Box 925
Valley Forge,  PA  19482
Correspondent Contact THOMAS J GILLOWAY
Regulation Number868.5915
Classification Product Code
BTM  
Date Received01/26/1993
Decision Date 03/11/1993
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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