CO2 RIGID LASER ENDOSCOPE PROBE SERIES 792/LAPARO

Laparoscope, Gynecologic (and Accessories)

SHARPLAN LASERS, INC.

The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Co2 Rigid Laser Endoscope Probe Series 792/laparo.

Pre-market Notification Details

Device IDK881010
510k NumberK881010
Device Name:CO2 RIGID LASER ENDOSCOPE PROBE SERIES 792/LAPARO
ClassificationLaparoscope, Gynecologic (and Accessories)
Applicant SHARPLAN LASERS, INC. 1 PEARL COURT Allendale,  NJ  07401
ContactStephen Dalton
CorrespondentStephen Dalton
SHARPLAN LASERS, INC. 1 PEARL COURT Allendale,  NJ  07401
Product CodeHET  
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-10
Decision Date1988-04-21

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