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510(k) K870600

Device
SOFT EAR STETHOSCOPE
Applicant
KALAJIAN ENT.
510(k) number
K870600
Product code
CBG  
Decision
Substantially Equivalent (SESE)
Decision date
1987-03-19
Date received
1987-02-10
Regulation
868.5760
Classification name
Spreader, Cuff
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KALAYJIAN, MD
Address
6601 Turkey Farm Rd. Chapel Hill NC US 27514 27514

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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