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510(k) K031548

Device
LED HEADLIGHT
Applicant
WELCH ALLYN, INC.
510(k) number
K031548
Product code
FSR  
Decision
Substantially Equivalent (SESE)
Decision date
2003-08-11
Date received
2003-05-16
Regulation
886.4335
Classification name
Light, Headband, Surgical
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAVID KLEMENTOWSKI
Address
4341 State St. Rd. P.O. Box 220 Skaneateles Falls NY US 13153 13153

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FSR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K110528INTEGRA LED SURGICAL HEADLIGHT SYSTEMIntegra LifeSciences Corporation2011-05-11
K031549SOLID STATE LAMP [LED] HEADLIGHTWelch Allyn, Inc.2003-08-11
K994362HEADLAMP HL2000.Angiolaz, Inc.2000-05-11

Legacy Summary#

summary

FDA Review#

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