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FDA 510(k) Application Details - K960194
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K960194
Device Name
Arthroscope
Applicant
MYELOTEC, INC.
55 NORTHERN BLVD.
SUITE 410
GREAT NECK, NY 11021 US
Other 510(k) Applications for this Company
Contact
CAROLANN KOTULA
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
01/16/1996
Decision Date
09/04/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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