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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 K070353
Device Name KELSEY INTERSITITAL LASER THERAPY SYSTEM
Applicant
Kelsey, Inc.
303 Patleigh Rd.
Catonsville,  MD  21228
Applicant Contact PAUL KETTERIDGE
Correspondent
Kelsey, Inc.
303 Patleigh Rd.
Catonsville,  MD  21228
Correspondent Contact PAUL KETTERIDGE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/06/2007
Decision Date 05/02/2007
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
Predetermined Change
Control Plan Authorized		 No
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