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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 K050108
Device Name SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS
Applicant
INNOVAQUARTZ
23030 NORTH 15TH AVE.
PHOENIX,  AZ  85027
Applicant Contact STEVE GRIFFIN
Correspondent
INNOVAQUARTZ
23030 NORTH 15TH AVE.
PHOENIX,  AZ  85027
Correspondent Contact STEVE GRIFFIN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/18/2005
Decision Date 03/14/2005
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
Recalls CDRH Recalls
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