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FDA 510(k) Application Details - K011727
Device Classification Name
Trocar
More FDA Info for this Device
510(K) Number
K011727
Device Name
Trocar
Applicant
THOMAS MEDICAL PRODUCTS, INC.
65 GREAT VALLEY PKWY.
MALVERN, PA 19355 US
Other 510(k) Applications for this Company
Contact
TIM STOUDT
Other 510(k) Applications for this Contact
Regulation Number
870.1390
More FDA Info for this Regulation Number
Classification Product Code
DRC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/04/2001
Decision Date
05/02/2002
Decision
SESE - SUBST EQUIV
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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