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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K860164
Device Name 2500 PRINTER
Applicant
Datascope Corp.
580 Winters Ave.
P.O. Box 5
Paramus,  NJ  07653
Applicant Contact ARTHUR FRIEDMAN
Correspondent
Datascope Corp.
580 Winters Ave.
P.O. Box 5
Paramus,  NJ  07653
Correspondent Contact ARTHUR FRIEDMAN
Date Received01/17/1986
Decision Date 06/05/1986
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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