Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K010425
Device Classification Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
More FDA Info for this Device
510(K) Number
K010425
Device Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Applicant
HDC CORP.
2109 O'TOOLE AVE.
SAN JOSE, CA 95131 US
Other 510(k) Applications for this Company
Contact
EARL SMART
Other 510(k) Applications for this Contact
Regulation Number
884.4160
More FDA Info for this Regulation Number
Classification Product Code
KNF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/13/2001
Decision Date
03/15/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact