Scope-Assist Flushing Sink

Accessories, Cleaning, For Endoscope

Custom Ultrasonics Inc.

The following data is part of a premarket notification filed by Custom Ultrasonics Inc. with the FDA for Scope-assist Flushing Sink.

Pre-market Notification Details

Device IDK162120
510k NumberK162120
Device Name:Scope-Assist Flushing Sink
ClassificationAccessories, Cleaning, For Endoscope
Applicant Custom Ultrasonics Inc. 144 Railroad Drive Ivyland,  PA  18974
ContactElizabeth Lazaro
CorrespondentElizabeth Lazaro
Custom Ultrasonics Inc. 144 Railroad Drive Ivyland,  PA  18974
Product CodeFEB  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-01
Decision Date2017-04-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
FLUSHINGSINKMODELS8 K162120 000
FLUSHINGSINKMODELS6 K162120 000
PPS83S8 K162120 000
PPS83S6 K162120 000
G434FLUSHINGSINKMODELS8 K162120 000
G434FLUSHINGSINKMODELS6 K162120 000
00860010835227 K162120 000
00860010835210 K162120 000

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