510(k) K830610

Device
FLAT SUCTION DRAIN
Applicant
SIL-MED CORP.
510(k) number
K830610
Product code
GBC  
Decision
Substantially Equivalent (SESE)
Decision date
1983-03-29
Date received
1983-02-25
Regulation
878.4580
Classification name
Lamp, Surgical, Incandescent
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
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 GBC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K896961HALUX EXLITE MINOR SURGERY LIGHTJedmed Instrument Co.1990-02-22
K811311SKYTRON ELITE SURGICAL TABLESSkytron, Div. the Kmw Group, Inc.1981-06-02
K810207MINOR SURGERY LIGHTCavitron Corp.1981-02-13

Legacy Summary#

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FDA Review#

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