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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 K022341
Device Name TERABYTE 2000 HAIR REMOVER
Applicant
TERABYTE CO.
5200 WOLF RUN SHOALS RD.
WOODBRIDGE,  VA  22192
Applicant Contact WILLIAM A OLSON
Correspondent
TERABYTE CO.
5200 WOLF RUN SHOALS RD.
WOODBRIDGE,  VA  22192
Correspondent Contact WILLIAM A OLSON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/18/2002
Decision Date 01/27/2003
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
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