IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER

Tray, Irrigation, Sterile

AMERICAN HEALTHCARE CORP.

The following data is part of a premarket notification filed by American Healthcare Corp. with the FDA for Irrigation Tray W/ Bulb Syringe & Sterile Water.

Pre-market Notification Details

Device IDK923939
510k NumberK923939
Device Name:IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER
ClassificationTray, Irrigation, Sterile
Applicant AMERICAN HEALTHCARE CORP. ONE AMERICAN HEALTHCARE PLAZA 3611 KENNEDY ROAD South Plainfield,  NJ  07080
ContactRalph S Jarrett
CorrespondentRalph S Jarrett
AMERICAN HEALTHCARE CORP. ONE AMERICAN HEALTHCARE PLAZA 3611 KENNEDY ROAD South Plainfield,  NJ  07080
Product CodeEYN  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-05
Decision Date1993-06-17

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