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510(k) K880827

Device
ACCUTEK PERIODONTAL PROBE
Applicant
SWEET MICRO SYSTEMS, INC.
510(k) number
K880827
Product code
EIX  
Decision
Substantially Equivalent (SESE)
Decision date
1988-04-12
Date received
1988-03-01
Regulation
872.4565
Classification name
Probe, Periodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
NICHOLAS H KONDON
Address
50 Fwy. Dr. Cranston RI US 02920 02920

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EIX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K960245VIP VICTOR INTERACTIVE PROBEPro-Dentec1996-04-04
K944848THE VIVACARE T.P.S. PROBERms Div.1994-12-14
K936221PROBE TIP/PERI PROBE/PERI PROBE COMP.Pd International AB1994-08-01
K890333ALBUMIN REAGENTAlpkem Corp.1989-02-17
K875076FLORIDA PROBEFlorida Probe Corp.1988-03-10
K870280ACCUDENT ACCUPROBEAccudent, Inc.1987-06-08
K871504DISPOSABLE PERIODONTAL PROBEPeriodontal Health Brush, Inc.1987-05-06
K823324DENTAL INSTRUMENTS - PROBESMiltex, Inc.1982-11-24

Legacy Summary#

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FDA Review#

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