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510(k) K891324

Device
HERMITEX SPONGE
Applicant
HERMITAGE HOSPITAL PRODUCTS, INC.
510(k) number
K891324
Product code
GER  
Decision
Substantially Equivalent (SESE)
Decision date
1989-04-27
Date received
1989-03-13
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#

Contact
JACK E ARNOULD
Address
38 Hope St. Niantic CT US 06357 06357

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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