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510(k) K952363

Device
OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)
Applicant
ELA MEDICAL, INC.
510(k) number
K952363
Product code
ELA  
Decision
Substantially Equivalent (SESE)
Decision date
1995-08-15
Date received
1995-05-01
Regulation
872.4565
Classification name
Instrument, Hand, Calculus Removal
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CAHTERINE GOBLE
Address
15245 Minnetonka Blvd. Minnetonka MN US 55345 55345

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ELA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K854168TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTESTravenol Laboratories, S.A.1986-03-13
K823326DENTAL INSTRUMENTS - CUTTING INSTRUMENTMiltex, Inc.1982-11-24
K801974ANALYTIC TECH. METAL POINT HEATER #3001Analytic Technology1980-11-12

Legacy Summary#

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FDA Review#

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