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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 K871579
Device Name MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE
Applicant
SHARPLAN LASERS, INC.
1 PEARL COURT
ALLENDALE,  NJ  07401
Applicant Contact STEPHEN DALTON
Correspondent
SHARPLAN LASERS, INC.
1 PEARL COURT
ALLENDALE,  NJ  07401
Correspondent Contact STEPHEN DALTON
Regulation Number884.4550
Classification Product Code
HHR  
Date Received04/23/1987
Decision Date 11/16/1987
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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