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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 NORTH WASHINGTON ST.
SUITE 400
ROCKVILLE,  MD  20850
Applicant Contact DANIEL GERSHONI
Correspondent
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
230 NORTH 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
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