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510(k) K855131

Device
SUTURE REMOVAL KIT
Applicant
DYNAREX CORP.
510(k) number
K855131
Product code
JOK  
Decision
Substantially Equivalent (SESE)
Decision date
1986-01-13
Date received
1985-12-23
Regulation
880.6820
Classification name
Scissors, Medical, Disposable
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MARVIN D SCHATTNER
Address
One International Blvd. Brewster NY US 10509 10509

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JOK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K843075UTILITY SCISSORS DISPOSABLE ITEMSGreene International Corp.1984-09-05
K812555DISPOSABLE SUTURE REMOVAL SCISSORSMedcare Products1981-11-16
K770595SUTURE REMOVAL SETAbco Dealers, Inc.1977-05-23
K770481SHEAR, PLASTIC HANDLE UTILITY S-475-7Acme United Corp.1977-04-29
K770163SUTURE CUTTERConcept, Inc.1977-03-30
K761192DRESSING CHANGE KITSuperior Plastic Products Corp.1977-02-28

Legacy Summary#

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FDA Review#

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