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510(k) K831912

Device
ROUND-BEEHIVE- DISSECTORS 3/8
Applicant
ORMED MFG., INC.
510(k) number
K831912
Product code
GDI  
Decision
Substantially Equivalent (SESE)
Decision date
1983-10-31
Date received
1983-06-14
Regulation
878.4800
Classification name
Dissector, 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
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GDI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K896383DISPOSABLE EXTERNAL CLAMPSGalenica Enterprises, Inc.1989-12-06
K850288HEPATIC PARENCHYMAL SUCTION DISSECTORBeecher Medical Diagnostic Instrumentation1985-03-18
K822569TYMPANOPLASTY & SKIN DISSECTORSKelleher Corp.1982-10-06
K803292FIELD SUCTION DISSECTORV. Mueller O.V. Baxter Healthcare Corp.1981-01-29
K791870DISPOSABLE SPECIALITY SPONGESCarwild Corp.1979-11-05
K791703TEW BYPASS INSTRUMENTS & DISSECTING KITEdward Weck, Inc.1979-10-04

Legacy Summary#

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FDA Review#

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