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510(k) K791703

Device
TEW BYPASS INSTRUMENTS & DISSECTING KIT
Applicant
EDWARD WECK, INC.
510(k) number
K791703
Product code
GDI  
Decision
Substantially Equivalent (SESE)
Decision date
1979-10-04
Date received
1979-08-28
Regulation
878.4800
Classification name
Dissector, Surgical, General & Plastic Surgery
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 GDI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K896383DISPOSABLE EXTERNAL CLAMPSGalenica Enterprises, Inc.1989-12-06
K850288HEPATIC PARENCHYMAL SUCTION DISSECTORBeecher Medical Diagnostic Instrumentation1985-03-18
K831912ROUND-BEEHIVE- DISSECTORS 3/8Ormed Mfg., Inc.1983-10-31
K822569TYMPANOPLASTY & SKIN DISSECTORSKelleher Corp.1982-10-06
K803292FIELD SUCTION DISSECTORV. Mueller O.V. Baxter Healthcare Corp.1981-01-29
K791870DISPOSABLE SPECIALITY SPONGESCarwild Corp.1979-11-05

Legacy Summary#

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FDA Review#

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