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510(k) K864865

Device
SPECULUM, VAGINAL, METAL FIBEROPTIC
Applicant
LUXTEC CORP.
510(k) number
K864865
Product code
HDG  
Decision
Substantially Equivalent (SESE)
Decision date
1987-01-09
Date received
1986-12-11
Regulation
884.4520
Classification name
Speculum, Vaginal, Metal, Fiberoptic
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
THOMAS WILK
Address
P.O. Box 225, Rte. 20/49 Techno Park Rd. Sturbridge MA US 01566 01566

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HDG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K771181VAGINAL ILLUMINATOR, MODEL 78570Welch Allyn, Inc.1977-07-14

Legacy Summary#

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FDA Review#

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