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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K900849
Device Name CARDISUNY, 501BX
Applicant
Graham-Field, Inc.
400 Rabro Dr. E.
Hauppauge,  NY  11788
Applicant Contact MARIA G SIMAT
Correspondent
Graham-Field, Inc.
400 Rabro Dr. E.
Hauppauge,  NY  11788
Correspondent Contact MARIA G SIMAT
Classification Product Code
LOS
Date Received02/22/1990
Decision Date 04/04/1990
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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