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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Neodymium:Yag, Pulmonary Surgery
510(k) Number K855095
Device Name S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWA
Applicant
Surgical Laser Technologies, Inc.
250 E 5th St. Suite 1500
Columbia Plz. Bldg.
Cincinnati,  OH  45202
Applicant Contact RICHARD L STUDER
Correspondent
Surgical Laser Technologies, Inc.
250 E 5th St. Suite 1500
Columbia Plz. Bldg.
Cincinnati,  OH  45202
Correspondent Contact RICHARD L STUDER
Regulation Number874.4500
Classification Product Code
LLO  
Date Received12/23/1985
Decision Date 02/18/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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