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510(k) K900691

Device
BIODYNE INSTRUMENT WIPES
Applicant
BIO-DYNE, INC.
510(k) number
K900691
Product code
GER  
Decision
Substantially Equivalent (SESE)
Decision date
1990-03-08
Date received
1990-02-13
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
ELIZABETH MELARAGNO
Address
4444 Topa Topa Dr. La Mesa CA US 92041 92041

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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