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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 K081977
Device Name PROSIT WOUND TREATMENT DEVICE
Applicant
Silverleaf Medical Products, Inc.
1100 E University Dr.
Suite 101
Tempe,  AZ  85281
Applicant Contact JEFFRY SKIBA
Correspondent
Silverleaf Medical Products, Inc.
1100 E University Dr.
Suite 101
Tempe,  AZ  85281
Correspondent Contact JEFFRY SKIBA
Classification Product Code
FRO  
Date Received07/11/2008
Decision Date 12/01/2008
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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