FDA 510(k) Application Details - K131221

Device Classification Name Maggots, Medical

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510(K) Number K131221
Device Name Maggots, Medical
Applicant BIOMONDE
62 FOREST STREET, STE 300
MARLBOROUGH, MA 01752 US
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Contact ROSINA ROBINSION, RN, MED, RAC
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Regulation Number 000.0000

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Classification Product Code NQK
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Date Received 04/30/2013
Decision Date 08/28/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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