REDDICK IRRIGATION/ASPIRATION SYSTEM

Needle, Aspiration And Injection, Disposable

IDEAL MEDICAL, INC.

The following data is part of a premarket notification filed by Ideal Medical, Inc. with the FDA for Reddick Irrigation/aspiration System.

Pre-market Notification Details

Device IDK910117
510k NumberK910117
Device Name:REDDICK IRRIGATION/ASPIRATION SYSTEM
ClassificationNeedle, Aspiration And Injection, Disposable
Applicant IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater,  FL  34622
ContactLorna Linville
CorrespondentLorna Linville
IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater,  FL  34622
Product CodeGAA  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-11
Decision Date1991-03-19

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