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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K150676
Device Name L-Mesitran Dressing Family II- Soft and Tulle
Applicant
Theo Manufacturing BV
Capucijnenstraat 71
Maastricht,  NL 6211 RP
Applicant Contact Monique Gottgens
Correspondent
Theo Manufacturing BV
Capucijnenstraat 71
Maastricht,  NL 6211 RP
Correspondent Contact Monique Gottgens
Classification Product Code
FRO  
Date Received03/16/2015
Decision Date 12/23/2015
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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