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510(k) K812711

Device
STERILE GAUZE PADS 12PLY
Applicant
MEDSPEC CORP.
510(k) number
K812711
Product code
GEL  
Decision
Substantially Equivalent (SESE)
Decision date
1981-11-02
Date received
1981-09-24
Regulation
510(k) Premarket Notification
Classification name
Gauze/sponge, Internal, 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
Jacob Bomberg
Address
65 E. Palatime #209 Prospect Heights IL US 60070 60070

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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