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510(k) K914035

Device
MINI-MILL
Applicant
BIOMEDICAL COMPOSITES, LTD.
510(k) number
K914035
Product code
EMI  
Decision
Substantially Equivalent (SESE)
Decision date
1992-03-02
Date received
1991-09-10
Regulation
872.4565
Classification name
File, Bone, Surgical
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RICHARD MULLARKY
Address
5464 Carpinteria Ave. #219 Carpinteria CA US 93013 93013

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EMI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K912989PLANUSTAR AND DENS NOBILIS DENTURE TEETHWilde-USA, Inc.1991-08-16
K851716865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILESArtiberia1985-06-11
K823676DISC NEEDLE SET #TX-8220Today'S Machining & Design, Inc.1983-01-09

Legacy Summary#

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FDA Review#

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