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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Removable (Skin)
510(k) Number K833085
Device Name STAPLE REMOVER SR300P
Applicant
Prosper, Inc.
Box 42
Richland,  MI  49083 -
Applicant Contact SYNCARE, INC.
Correspondent
Prosper, Inc.
Box 42
Richland,  MI  49083 -
Correspondent Contact SYNCARE, INC.
Regulation Number878.4760
Classification Product Code
GDT  
Date Received09/12/1983
Decision Date 12/14/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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