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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, Surgical, General Use
510(k) Number K990062
Device Name SAPHLIFT
Applicant
Genzyme Surgical Product (Genzyme Biosurgery)
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact Ruth Forstadt
Correspondent
Genzyme Surgical Product (Genzyme Biosurgery)
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact Ruth Forstadt
Regulation Number878.4800
Classification Product Code
MDM  
Subsequent Product Code
GCJ  
Date Received01/08/1999
Decision Date 03/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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