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FDA 510(k) Application Details - K980689
Device Classification Name
Tong, Skull For Traction
More FDA Info for this Device
510(K) Number
K980689
Device Name
Tong, Skull For Traction
Applicant
FRIDDLE'S ORTHOPEDIC APPLIANCES, INC.
12306 BELTON HONEA PATH HWY.
HONEA PATH, SC 29654 US
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Contact
FRANK E FRIDDLE, JR.
Other 510(k) Applications for this Contact
Regulation Number
882.5960
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Classification Product Code
HAX
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More FDA Info for this Product Code
Date Received
02/23/1998
Decision Date
02/18/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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