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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K864167
Device Name PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED)
Applicant
Datascope Corp.
3 Fir Ct.
P.O. Box 3100
Oakland,  NJ  07436
Applicant Contact SCHNEIDER, PH.D
Correspondent
Datascope Corp.
3 Fir Ct.
P.O. Box 3100
Oakland,  NJ  07436
Correspondent Contact SCHNEIDER, PH.D
Date Received10/24/1986
Decision Date 11/06/1986
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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