ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)

Endoilluminator

AMERICAN MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by American Medical Devices, Inc. with the FDA for Endolight End Irrigating Endo-illuminator (20 Ga. And 19 Ga.).

Pre-market Notification Details

Device IDK970882
510k NumberK970882
Device Name:ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)
ClassificationEndoilluminator
Applicant AMERICAN MEDICAL DEVICES, INC. 1100 NORTHSIDE DR. Atlanta,  GA  30318
ContactFrank J Tighe
CorrespondentFrank J Tighe
AMERICAN MEDICAL DEVICES, INC. 1100 NORTHSIDE DR. Atlanta,  GA  30318
Product CodeMPA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-10
Decision Date1997-06-24
Summary:summary

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