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510(k) K892069

Device
EXTENDED COVERS, STERILE
Applicant
AMEDIC USA
510(k) number
K892069
Product code
FFF  
Decision
Substantially Equivalent (SESE)
Decision date
1989-08-08
Date received
1989-03-31
Regulation
876.1075
Classification name
Cover, Biopsy Forceps
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ANDERS WEILANDT
Address
Oxenstiernsgatan 31 115 27 Stockholm Sweden SE

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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