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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Noninvasive
510(k) Number K952605
Device Name SUCTION/IRRIGATOR TUBING KIT
Applicant
Surgical Laser Technologies, Inc.
200 Cresson Blvd.
P.O.Box 880
Oaks,  PA  19456
Applicant Contact RICHARD G JONES
Correspondent
Surgical Laser Technologies, Inc.
200 Cresson Blvd.
P.O.Box 880
Oaks,  PA  19456
Correspondent Contact RICHARD G JONES
Regulation Number880.6740
Classification Product Code
GAZ  
Subsequent Product Code
GEX  
Date Received06/06/1995
Decision Date 09/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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