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FDA 510(k) Application Details - K974376
Device Classification Name
Manipulator, Plunger-Like Joint
More FDA Info for this Device
510(K) Number
K974376
Device Name
Manipulator, Plunger-Like Joint
Applicant
J-TECH MEDICAL, INC.
PO BOX 4341
CROFTON, MD 21114 US
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Contact
E.J SMITH
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
LXM
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More FDA Info for this Product Code
Date Received
11/20/1997
Decision Date
02/18/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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