SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP

Laser, Ophthalmic

COHERENT MEDICAL GROUP

The following data is part of a premarket notification filed by Coherent Medical Group with the FDA for System 920 Photocoagulator To Include Schirmerscop.

Pre-market Notification Details

Device IDK844358
510k NumberK844358
Device Name:SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOP
ClassificationLaser, Ophthalmic
Applicant COHERENT MEDICAL GROUP 4221 Richmond Rd., N.W. Walker,  MI  49534
ContactTheodore A Boutacof
CorrespondentTheodore A Boutacof
COHERENT MEDICAL GROUP 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeHQF  
CFR Regulation Number886.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-11-09
Decision Date1985-01-03

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