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FDA 510(k) Application Details - K970233
Device Classification Name
Catheter, Peripheral, Atherectomy
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510(K) Number
K970233
Device Name
Catheter, Peripheral, Atherectomy
Applicant
GARY A. GELBFISH
12300 TWINBROOK PKWY.
SUITE 625
ROCKVILLE, MD 20852 US
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Contact
ROBERT L SHERIDAN
Other 510(k) Applications for this Contact
Regulation Number
870.4875
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Classification Product Code
MCW
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More FDA Info for this Product Code
Date Received
01/21/1997
Decision Date
10/08/1997
Decision
SESK - SUBST EQUIV - KIT
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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