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510(k) K992995

Device
AROMATIC AND FLAVORED TONGUE DEPRESSOR
Applicant
AGA PLASTIC IND. COM. LTDA.
510(k) number
K992995
Product code
FMA  
Decision
Substantially Equivalent (SESE)
Decision date
1999-12-09
Date received
1999-09-07
Regulation
880.6230
Classification name
Depressor, Tongue, Non-surgical
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SUSAN D GOLDSTEIN-FALK
Address
55 Northern Blvd., Suite 200 Great Neck NY US 11021 11021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FMA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K842461TONGUE DEPRESSORThe Torrent Corp.1984-11-30
K830705MINI LANCET-BLOOD LANCETPharmaquest Corp.1983-04-08
K821177BITE STICKAbco Dealers, Inc.1982-05-21
K770120MOUTH WASH TRAYPharmaseal Div., Baxter Healthcare Corp.1977-01-28

Legacy Summary#

summary

FDA Review#

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