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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 K832709
Device Name SKIN STAPLING DEVICE SC2000
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 Received08/12/1983
Decision Date 09/26/1983
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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