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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Maggots, Medical
510(k) Number K123449
Device Name BIOMONDE LARVAE
Applicant
Biomonde (A Trading Name of Zoobiotic Limited)
225 Turnpike Rd.
Southbrough,  MA  01772
Applicant Contact ROSINA ROBINSON RN, MED, RAC
Correspondent
Biomonde (A Trading Name of Zoobiotic Limited)
225 Turnpike Rd.
Southbrough,  MA  01772
Correspondent Contact ROSINA ROBINSON RN, MED, RAC
Classification Product Code
NQK  
Date Received11/09/2012
Decision Date 03/05/2013
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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