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FDA 510(k) Application Details - K955730
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K955730
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
ELECTRO-BIOLOGY, INC.
6 UPPER POND RD.
P.O. BOX 345
PARSIPPANY, NJ 07054 US
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Contact
SHARON A STAROWICZ
Other 510(k) Applications for this Contact
Regulation Number
888.3060
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Classification Product Code
KWQ
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More FDA Info for this Product Code
Date Received
12/18/1995
Decision Date
03/13/1996
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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