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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 K003318
Device Name PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X
Applicant
Paradigm Medical Industries, Inc.
2355 S. 1070 W.
Salt Lake City,  UT  84119
Applicant Contact TRACY S BEST
Correspondent
Paradigm Medical Industries, Inc.
2355 S. 1070 W.
Salt Lake City,  UT  84119
Correspondent Contact TRACY S BEST
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/24/2000
Decision Date 05/22/2001
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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