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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 K131221
Device Name LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400
Applicant
Biomonde
62 Forest St., Suite 300
Marlborough,  MA  01752
Applicant Contact ROSINA ROBINSION, RN, MED, RAC
Correspondent
Biomonde
62 Forest St., Suite 300
Marlborough,  MA  01752
Correspondent Contact ROSINA ROBINSION, RN, MED, RAC
Classification Product Code
NQK  
Date Received04/30/2013
Decision Date 08/28/2013
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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