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Manufacturers
US
Deroyal
Medical Device Manufacturer
·
US , Knoxville , TN
Deroyal - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2002
Official Website
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Deroyal
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 20, 2003
DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE
K033057
·
FYA
General Hospital
·
52d
Cleared
Oct 15, 2003
DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)
K031408
·
FYA
General Hospital
·
163d
Cleared
Aug 11, 2003
DEROYAL SURGICAL DRAPES BACKTABLE COVER
K030908
·
KKX
General Hospital
·
140d
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5
General Hospital
3
Gastroenterology & Urology
1
Hematology
1