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510(k) K912472

Device
DEROYAL WOUND DRESSING
Applicant
DEROYAL INDUSTRIES, INC.
510(k) number
K912472
Product code
MGO  
Decision
Substantially Equivalent (SESE)
Decision date
1991-10-02
Date received
1991-06-04
Regulation
878.4018
Classification name
Closure, Wound, Adhesive
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DEBRA F MANNING
Address
200 Debusk Ln. Powell TN US 37849 37849

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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