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510(k) K994362

Device
HEADLAMP HL2000.
Applicant
ANGIOLAZ, INC.
510(k) number
K994362
Product code
FSR  
Decision
Substantially Equivalent (SESE)
Decision date
2000-05-11
Date received
1999-12-27
Regulation
886.4335
Classification name
Light, Headband, Surgical
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ROBERT ALLMAN
Address
P.O. Box 556 Industrial Park Bellows Falls VT US 05101 05101

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K031548LED HEADLIGHTWelch Allyn, Inc.2003-08-11
K031549SOLID STATE LAMP [LED] HEADLIGHTWelch Allyn, Inc.2003-08-11

Legacy Summary#

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FDA Review#

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