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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Peak Flow, Spirometry
510(k) Number K934795
Device Name CARD GUARD
Applicant
Card Guard Scientific Survival , Ltd.
230 N. Washington St.
Suite 400
Rockville,  MD  20850
Applicant Contact DANIEL GERSHONI
Correspondent
Card Guard Scientific Survival , Ltd.
230 N. Washington St.
Suite 400
Rockville,  MD  20850
Correspondent Contact DANIEL GERSHONI
Regulation Number868.1860
Classification Product Code
BZH  
Date Received10/06/1993
Decision Date 04/14/1995
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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