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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K863608
Device Name DATASCOPE BALLOON DILATATION CATHETER
Applicant
Datascope Corp.
3 Fir Ct.
P.O. Box 3100
Oakland,  NJ  07436
Applicant Contact STEVE KONTOS
Correspondent
Datascope Corp.
3 Fir Ct.
P.O. Box 3100
Oakland,  NJ  07436
Correspondent Contact STEVE KONTOS
Date Received09/16/1986
Decision Date 02/10/1987
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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