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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K952299
Device Name SURGISCAN SCANNER
Applicant
Norcross Scientific
6015 B Unity Dr.
Norcross,  GA  30071
Applicant Contact LORNA K LINVILLE
Correspondent
Norcross Scientific
6015 B Unity Dr.
Norcross,  GA  30071
Correspondent Contact LORNA K LINVILLE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/16/1995
Decision Date 07/17/1995
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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