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510(k) K801610

Device
CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR
Applicant
EDWARD WECK, INC.
510(k) number
K801610
Product code
GCZ  
Decision
Substantially Equivalent (SESE)
Decision date
1980-08-04
Date received
1980-07-15
Regulation
878.4800
Classification name
Retainer, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
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 GCZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K904536JAIN GRAFT ASSISTJain Surgical Equipment, Inc.1990-11-29
K893870ADAMS BREAST IMPLANT PROTECTORAdept-Med Intl., Inc.1989-07-14
K870809MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206Adept-Med Intl., Inc.1987-03-19
K802806VISECERA RETAINERAdept-Med Intl., Inc.1981-01-23

Legacy Summary#

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FDA Review#

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