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FDA 510(k) Application Details - K972768
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K972768
Device Name
Arthroscope
Applicant
BLACKSTONE MEDICAL, INC.
90 BROOKDALE DR.
SPRINGFIELD, MA 01104 US
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Contact
JOSEPH S MOONEY
Other 510(k) Applications for this Contact
Regulation Number
888.1100
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Classification Product Code
HRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/24/1997
Decision Date
09/25/1997
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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