FDA 510(k) Applications for Medical Device:
Polymer, Ear, Nose And Throat, Synthetic, Absorbable

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K183015 3-D Matrix, Inc. 250 First Ave., Suite 205
Needham MA 02494
K192661 Entellus Medical, Inc. (Aka Stryker ENT) 3600 Holly Lane North, Suite 40
Plymouth MN 55447
K092590 ETHICON, INC. U.S. ROUTE 22, WEST
SOMERVILLE NJ 08876-0151
K210411 Hemostasis LLC 5000 Township Pkwy
St Paul MN 55110
K012769 MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST.
SAN DIEGO CA 92121
K070886 MEDTRONIC INC. 6743 SOUTHPOINT DRIVE NORTH
JACKSONVILLE FL 32259
K122434 MEDTRONIC XOMED 6743 SOUTHPOINT DR. NORTH
JACKSONVILLE FL 32216
K070715 Polyganics BV L.J. ZIELSTRAWEG 1
GRONINGEN 9713-GX
K223167 Spirair, Inc. 6084 Monterey Hwy, 108
San Jose CA 95138
K152958 SPIROX, INC. 3475-O EDISON WAY
MENLO PARK CA 94025
K161191 SPIROX, INC. 3475-O EDISON WAY
MENLO PARK CA 94025
K132920 SPIROX, INC. 381 ARLINGTON WAY
MENLO PARK CA 94025
K012409 WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR.
JACKSONVILLE FL 32218




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