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510(k) K810379

Device
EARETTE HEARING AID SEARS #8054
Applicant
OTICON CORP.
510(k) number
K810379
Product code
FSD  
Decision
Substantially Equivalent (SESE)
Decision date
1981-03-04
Date received
1981-02-13
Regulation
880.5160
Classification name
Binder, Abdominal
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 FSD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K892379THE POUCH GROIN & ABDOMINAL STRESS AIDKuhn Industries1989-07-20
K822817DOCE ALL-IN-THE-EAR AIDFidelty Hearing Instruments, Inc.1983-01-18
K770162MATERNITY SUPPORTERR.G. Moore1977-02-09
K760772DISPOSABLE ABDOMINAL BINDERTecnol New Jersey Wound Care, Inc.1976-11-03

Legacy Summary#

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FDA Review#

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