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510(k) K810019

Device
SURG-FLEX 15 SURGICAL LIGHT
Applicant
MEDICAL PRODUCTS DEVELOPMENT, INC.
510(k) number
K810019
Product code
FSQ  
Decision
Substantially Equivalent (SESE)
Decision date
1981-01-23
Date received
1981-01-05
Regulation
878.4580
Classification name
Light, Surgical, Instrument
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 FSQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K930686MIDMARK SURGICAL LIGHTING SYSTEMSMidmark Corp.1993-07-30
K932139LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFTAaron Medical Industries1993-07-30
K922409ALM ILLUMINATOR SERIES LIGHT SYSTEMAlm Surgical Equipment, Inc.1993-01-12
K921848BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHTAlm Surgical Equipment, Inc.1992-10-01
K803067SURG-FLEX 10 LIGHTMedical Products Development, Inc.1981-02-26
K810018SURG-FLEX 5 SURGICAL LIGHTMedical Products Development, Inc.1981-01-23

Legacy Summary#

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FDA Review#

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