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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 K883541
Device Name METALASER VASCULASE
Applicant
Metatech Corp.
1244 Quarry Ln.
Pleasanton,  CA  94566
Applicant Contact JEFFREY C WEBBER
Correspondent
Metatech Corp.
1244 Quarry Ln.
Pleasanton,  CA  94566
Correspondent Contact JEFFREY C WEBBER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/19/1988
Decision Date 11/04/1988
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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