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510(k) K890374

Device
ABDOMINAL SPATULA
Applicant
KINETIC MEDICAL PRODUCTS
510(k) number
K890374
Product code
GAF  
Decision
Substantially Equivalent (SESE)
Decision date
1989-02-03
Date received
1989-01-23
Regulation
878.4800
Classification name
Spatula, 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#

Contact
JAMES I LAUGHNER
Address
4934 Peach St. Erie PA US 16509 16509

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GAF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K023688LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPERLeMaitre Vascular, Inc.2003-01-30
K935357SNAP RECIPROCATING SAWSurgiquip, Inc.1994-01-28
K882793PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINEPmt Corp.1988-07-18
K822108CEMENT-PICKBio-Blitz, Inc.1982-08-11

Legacy Summary#

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FDA Review#

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