FDA 510(k) Application Details - K072251

Device Classification Name Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained

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510(K) Number K072251
Device Name Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Applicant MERETE MEDICAL GMBH
49 PURCHASE STREET
RYE, NY 10580 US
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Contact DONNA COLEMAN
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Regulation Number 000.0000

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Classification Product Code LZJ
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Date Received 08/13/2007
Decision Date 05/08/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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