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510(k) K821177

Device
BITE STICK
Applicant
ABCO DEALERS, INC.
510(k) number
K821177
Product code
FMA  
Decision
Substantially Equivalent (SESE)
Decision date
1982-05-21
Date received
1982-04-27
Regulation
880.6230
Classification name
Depressor, Tongue, Non-surgical
Medical specialty
General Hospital
Review panel
General Hospital
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 FMA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K992995AROMATIC AND FLAVORED TONGUE DEPRESSORAga Plastic Ind. Com. Ltda.1999-12-09
K842461TONGUE DEPRESSORThe Torrent Corp.1984-11-30
K830705MINI LANCET-BLOOD LANCETPharmaquest Corp.1983-04-08
K770120MOUTH WASH TRAYPharmaseal Div., Baxter Healthcare Corp.1977-01-28

Legacy Summary#

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FDA Review#

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