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510(k) K780349

Device
VAGINAL RETRACTOR
Applicant
EDWARD WECK, INC.
510(k) number
K780349
Product code
HDL  
Decision
Substantially Equivalent (SESE)
Decision date
1978-03-14
Date received
1978-03-03
Regulation
884.4520
Classification name
Retractor, Vaginal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HDL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K891038VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKYZinnanti Surgical Instruments, Inc.1989-03-17

Legacy Summary#

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FDA Review#

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