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510(k) K803116

Device
HEAVY DRAINAGE PACK
Applicant
AMERICAN MEDICAL DISPOSABLE, INC.
510(k) number
K803116
Product code
GER  
Decision
Substantially Equivalent (SESE)
Decision date
1981-01-28
Date received
1980-12-10
Regulation
510(k) Premarket Notification
Classification name
Gauze, External (with Drug/biologic/animal Source Material)
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
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

Legacy Summary#

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FDA Review#

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