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510(k) K822277

Device
ROSEN'S STAPES NEEDLE EXPLORER
Applicant
KELLEHER CORP.
510(k) number
K822277
Product code
KAK  
Decision
Substantially Equivalent (SESE)
Decision date
1982-08-25
Date received
1982-07-29
Regulation
874.4420
Classification name
Probe, Ent
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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