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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K881010
Device Name CO2 RIGID LASER ENDOSCOPE PROBE SERIES 792/LAPARO
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 Number884.1720
Classification Product Code
HET  
Date Received03/10/1988
Decision Date 04/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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