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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(k) Number K983050
Device Name PNEUMATIC CUTTER SYSTEM
Applicant
Surgical Laser Technologies, Inc.
147 Keystone Dr.
Montgomeryville,  PA  18936
Applicant Contact MONICA FERRANTE
Correspondent
Surgical Laser Technologies, Inc.
147 Keystone Dr.
Montgomeryville,  PA  18936
Correspondent Contact MONICA FERRANTE
Regulation Number874.4250
Classification Product Code
ERL  
Date Received09/01/1998
Decision Date 11/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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