PROXENON 350, MODEL 902XX

Light, Surgical, Fiberoptic

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Proxenon 350, Model 902xx.

Pre-market Notification Details

Device IDK071218
510k NumberK071218
Device Name:PROXENON 350, MODEL 902XX
ClassificationLight, Surgical, Fiberoptic
Applicant WELCH ALLYN, INC. 4341 STATE STREET ROAD PO BOX 220 Skaneateles Falls,  NY  13153 -0220
ContactJohn E Sawyer
CorrespondentJohn E Sawyer
WELCH ALLYN, INC. 4341 STATE STREET ROAD PO BOX 220 Skaneateles Falls,  NY  13153 -0220
Product CodeFST  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-02
Decision Date2007-06-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H834902200 K071218 000

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