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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 K981041
Device Name SLT BIPOLAR SHEATH
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  
Subsequent Product Code
GEI  
Date Received03/20/1998
Decision Date 08/27/1998
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
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