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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 K972272
Device Name LASER PERIPHERALS HOLMIUM BARE FIBERS
Applicant
Laser Peripherals, LLC
5484 Feltl Rd.
Minnetonka,  MN  55343
Applicant Contact NANCY L ARNOLD
Correspondent
Laser Peripherals, LLC
5484 Feltl Rd.
Minnetonka,  MN  55343
Correspondent Contact NANCY L ARNOLD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/18/1997
Decision Date 07/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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