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FDA 510(k) Application Details - K081359
Device Classification Name
Device, Counter-Pulsating, External
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510(K) Number
K081359
Device Name
Device, Counter-Pulsating, External
Applicant
SCOTTCARE CORPORATION
4791 WEST 150TH ST.
CLEVELAND, OH 44135 US
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Contact
RONALD J CLINES
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Regulation Number
870.5225
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Classification Product Code
DRN
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More FDA Info for this Product Code
Date Received
05/15/2008
Decision Date
05/29/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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