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510(k) K882793

Device
PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE
Applicant
PMT CORP.
510(k) number
K882793
Product code
GAF  
Decision
Substantially Equivalent (SESE)
Decision date
1988-07-18
Date received
1988-07-06
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
ALFRED A IVERSEN
Address
1500 Park Rd. Chanhassen MN US 55317 55317

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
K890374ABDOMINAL SPATULAKinetic Medical Products1989-02-03
K822108CEMENT-PICKBio-Blitz, Inc.1982-08-11

Legacy Summary#

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FDA Review#

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