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510(k) K821358

Device
MODIFIED RONGEURS FOR SPINAL & ORTH. S.
Applicant
DOWNS SURGICAL LTD.
510(k) number
K821358
Product code
EMH  
Decision
Substantially Equivalent (SESE)
Decision date
1982-05-28
Date received
1982-05-06
Regulation
872.4565
Classification name
Forceps, Rongeur, Surgical
Medical specialty
Dental
Review panel
Dental
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 EMH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K890255BONE RONGEUR, SINGLE-ACTIONKinetic Medical Products1989-01-27
K890256BONE RONGEUR, DOUBLE-ACTIONKinetic Medical Products1989-01-27
K854887MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLATWalter Lorenz Surgical, Inc.1986-02-28
K851710586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORCArtiberia1985-06-11
K834190JAKOBI SURG. INSTRUMENTS #8 15Imm Enterprises , Ltd.1984-03-06
K834366SURGICAL INSTRUMENTS & ACCESSORIESC.B.S. Biotechnics, Inc.1984-02-27
K771522FORCEPS, STYLE #849Premier Dental Products Co.1977-08-16

Legacy Summary#

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FDA Review#

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