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510(k) K780289

Device
NERVE APPROXIMATER
Applicant
EDWARD WECK, INC.
510(k) number
K780289
Product code
GDG  
Decision
Substantially Equivalent (SESE)
Decision date
1978-06-14
Date received
1978-02-21
Regulation
878.4800
Classification name
Hook, 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 GDG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K900069MODIFIED PGL ABSORBABLE STAPLE*United States Surgical, A Division of Tyco Healthc1990-04-16
K891898SKIN HOOKS, VARIOUS TYPESZinnanti Surgical Instruments, Inc.1989-04-12
K864425RAYLOR(TM) DISSECTING HOOKCedar Surgical, Inc.1986-12-12
K843136BRIMFIELD CANNULATED GRASPING HOOKSBrimfield Scientific Instruments1984-09-25
K841010SURGICAL HOOKS, VARIOUSPremier Dental Products Co.1984-05-01
K812562SURGICAL RETRACTOR & ELASTIC STAYS, DISPHumboldt Products1981-10-02
K791120MIDDLE EAR PICKS, HOOKS CURETTES,Xomed, Inc.1979-07-10
K771187DERMAHOOK #382-805Edward Weck, Inc.1977-07-11
K771190ABRAMSON TRACHEA HOOK & RETRACTOREdward Weck, Inc.1977-07-11

Legacy Summary#

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FDA Review#

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