Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K964919
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K964919
Device Name
Arthroscope
Applicant
EMERALD MEDICAL, INC.
MILL LN. RD.
BRIMFIELD, MA 01010 US
Other 510(k) Applications for this Company
Contact
JOSEPH S MOONEY
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
12/09/1996
Decision Date
01/28/1997
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact