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510(k) K921848

Device
BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT
Applicant
ALM SURGICAL EQUIPMENT, INC.
510(k) number
K921848
Product code
FSQ  
Decision
Substantially Equivalent (SESE)
Decision date
1992-10-01
Date received
1992-04-17
Regulation
878.4580
Classification name
Light, Surgical, Instrument
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SUSAN NIELSEN
Address
3323 W. Warner Ave. Santa Ana CA US 92704 92704

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K803067SURG-FLEX 10 LIGHTMedical Products Development, Inc.1981-02-26
K810018SURG-FLEX 5 SURGICAL LIGHTMedical Products Development, Inc.1981-01-23
K810019SURG-FLEX 15 SURGICAL LIGHTMedical Products Development, Inc.1981-01-23

Legacy Summary#

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FDA Review#

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