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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 K160783
FOIA Releasable 510(k) K160783
Device Name Procellera
Applicant
Vomaris Innovations, Inc.
1911 E. 5th St.
Tempe,  AZ  85281
Applicant Contact Timothy Joiner
Correspondent
Vomaris Innovations, Inc.
1911 E. 5th St.
Tempe,  AZ  85281
Correspondent Contact Timothy Joiner
Classification Product Code
FRO  
Date Received03/22/2016
Decision Date 09/07/2016
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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