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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 K020673
Device Name WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER
Applicant
WAVE FORM MFG., INC.
8317 FRONT BEACH RD.
SUITE 21
PANAMA CITY BEACH,  FL  32407
Applicant Contact JOE D BROWN
Correspondent
WAVE FORM MFG., INC.
8317 FRONT BEACH RD.
SUITE 21
PANAMA CITY BEACH,  FL  32407
Correspondent Contact JOE D BROWN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/01/2002
Decision Date 05/30/2002
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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