LED HEADLIGHT

Light, Headband, Surgical

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Led Headlight.

Pre-market Notification Details

Device IDK031548
510k NumberK031548
Device Name:LED HEADLIGHT
ClassificationLight, Headband, Surgical
Applicant WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
ContactDavid Klementowski
CorrespondentDavid Klementowski
WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
Product CodeFSR  
CFR Regulation Number886.4335 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-16
Decision Date2003-08-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00732094073089 K031548 000
00732094004571 K031548 000
00732094001679 K031548 000
00732094001723 K031548 000
00732094002485 K031548 000
00732094002492 K031548 000
00732094041835 K031548 000
00732094071818 K031548 000
00732094072143 K031548 000
00732094072150 K031548 000
00732094072167 K031548 000
00732094072174 K031548 000
00732094072198 K031548 000
00732094073065 K031548 000
00732094073072 K031548 000
00732094004564 K031548 000

Trademark Results [LED HEADLIGHT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LED HEADLIGHT
LED HEADLIGHT
90894279 not registered Live/Pending
Solaris Lumenis inc
2021-08-20

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