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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, surgical, gynecologic
510(k) Number K872254
Device Name SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL
Applicant
SURGICAL LASER TECHNOLOGIES, INC.
ONE GREAT VALLEY PKWY.
MALVERN,  PA  19355
Applicant Contact GIFFORD, R.N.
Correspondent
SURGICAL LASER TECHNOLOGIES, INC.
ONE GREAT VALLEY PKWY.
MALVERN,  PA  19355
Correspondent Contact GIFFORD, R.N.
Regulation Number884.4550
Classification Product Code
HHR  
Date Received05/20/1987
Decision Date 12/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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