MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA

Laser For Gastro-urology Use

SHARPLAN INDUSTRIES, INC.

The following data is part of a premarket notification filed by Sharplan Industries, Inc. with the FDA for Model 2100 Nd:yag Surgical Laser Urological Indica.

Pre-market Notification Details

Device IDK861046
510k NumberK861046
Device Name:MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA
ClassificationLaser For Gastro-urology Use
Applicant SHARPLAN INDUSTRIES, INC. C/O KLEINFELD, KAPLAN & BECKER 1140 NINETEENTH STREET, N.W. Washington,  DC  20036
ContactPeter Safir
CorrespondentPeter Safir
SHARPLAN INDUSTRIES, INC. C/O KLEINFELD, KAPLAN & BECKER 1140 NINETEENTH STREET, N.W. Washington,  DC  20036
Product CodeLNK  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-18
Decision Date1986-05-02

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