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FDA 510(k) Application Details - K962075
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K962075
Device Name
Arthroscope
Applicant
HENKE SASS WOLF OF AMERICA, INC.
SOROCO INDUSTRIAL PARK
ROUTE 131
SOUTHBRIDGE, MA 01550 US
Other 510(k) Applications for this Company
Contact
JOHN M SMITH
Other 510(k) Applications for this Contact
Regulation Number
888.1100
More FDA Info for this Regulation Number
Classification Product Code
HRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/28/1996
Decision Date
01/17/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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