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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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