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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Balloon, Intra-Aortic And Control
510(k) Number K020257
Device Name DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S
Applicant
Datascope Corp.
15 Law Dr.
Fairfield,  NJ  07004 -3206
Applicant Contact JOANN WOLF
Correspondent
Datascope Corp.
15 Law Dr.
Fairfield,  NJ  07004 -3206
Correspondent Contact JOANN WOLF
Regulation Number870.3535
Classification Product Code
DSP  
Date Received01/24/2002
Decision Date 04/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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