FDA 510(k) Application Details - K980689

Device Classification Name Tong, Skull For Traction

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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.
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Regulation Number 882.5960

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Classification Product Code HAX
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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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