FDA 510(k) Application Details - K961433

Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

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510(K) Number K961433
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant ELECTRO-BIOLOGY, INC.
6 UPPER POND RD.
P.O. BOX 345
PARSIPPANY, NJ 07054 US
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Contact SHARON A STAROWICZ
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Regulation Number 888.3030

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Classification Product Code KTT
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Date Received 04/15/1996
Decision Date 06/28/1996
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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