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510(k) K910687

Device
GUARDIAN GEL, SURGEON'S GLOVING CREAM
Applicant
GUARDIAN ANGEL PRODUCTS, INC.
510(k) number
K910687
Product code
KGQ  
Decision
Substantially Equivalent (SESE)
Decision date
1991-10-11
Date received
1991-02-19
Regulation
878.4470
Classification name
Cream, Gloving, Surgeon's
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
HOWARD M HOLSTEIN
Address
Columbia Sq. 555 Thirteeth St. NW Washington DC US 20004 20004

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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