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510(k) K780291

Device
ULNAR-RADIAL APPROXIMATER
Applicant
EDWARD WECK, INC.
510(k) number
K780291
Product code
GDJ  
Decision
Substantially Equivalent (SESE)
Decision date
1978-02-28
Date received
1978-02-21
Regulation
878.4800
Classification name
Clamp, 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 GDJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K153358Standard ClampStandard Bariatrics2016-05-02
K930315THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCEThomasville Medical Assoc.1994-02-04
K924223MAR-MED LIVER STRAPMar-Med Co.1993-03-18
K922659GENERAL SURGERY CLAMP AND NEEDLE HOLDERMiltex Instrument Co.1992-07-21
K914913GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYSTIdeal Medical, Inc.1991-12-31
K900956GS-7100 CHOLANGIOGRAM CLAMP, 5MMSolos Endoscopy, Inc.1990-04-18
K901107MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATICUnited States Surgical, A Division of Tyco Healthc1990-04-09
K895726VESSEL OCCLUDERApplied Medical Technologies1989-10-24
K895591SILICONE INSTRUMENT SHODSKey Surgical, Inc.1989-10-20
K882169SURGICAL DUCT CLAMP (VINE)Henley Intl.1988-06-17
K881741STUART LEE CLIPStuart-Lee, Inc.1988-06-03
K881084UTILITY CLAMPMed-Dex Intl.1988-03-25
K874428AUTO SUTURE PURSE STRING APPLIER*United States Surgical, A Division of Tyco Healthc1987-12-02
K855144TOURIQUET KIT WITH SNAREDlp, Inc.1986-02-05
K853583MODERN MEDICAL PRODUCTS TOWEL CLAMPModern Medical Products1985-09-16

Legacy Summary#

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FDA Review#

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