SHARPLAN 1075 CO2 LASER

Powered Laser Surgical Instrument

SHARPLAN LASERS, INC.

The following data is part of a premarket notification filed by Sharplan Lasers, Inc. with the FDA for Sharplan 1075 Co2 Laser.

Pre-market Notification Details

Device IDK893206
510k NumberK893206
Device Name:SHARPLAN 1075 CO2 LASER
ClassificationPowered Laser Surgical Instrument
Applicant SHARPLAN LASERS, INC. 1 PEARL COURT Allendale,  NJ  07401
ContactKenneth Raichman
CorrespondentKenneth Raichman
SHARPLAN LASERS, INC. 1 PEARL COURT Allendale,  NJ  07401
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-26
Decision Date1989-06-21

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