FDA 510(k) Applications for Medical Device:
Lubricant, Patient

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K083189 AVAIL MEDICAL PRODUCTS, INC. 1900 CARNEGIE AVE.
SANTA ANA CA 92705
K020586 BIOFILM, INC. 3121 SCOTT ST.
VISTA CA 92083
K041060 CHESTER LABS, INC. 1900 SECTION RD.
CINCINNATI OH 45237
K113689 DUKAL CORPORATION 2 FLEETWOOD CT
RONKONKOMA NY 11779
K092488 DYNAREX CORPORATION 10 GLENSHAW ST.
ORANGEBURG NY 10962
K112110 JIANERKANG MEDICAL DRESSING COMPANY ZHIXI TOWN
JINTAN CITY, JIANGSU 213251
K103718 MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE
MUNDELEIN IL 60060
K974768 NICE-PAK PRODUCTS, INC. TWO NICE-PAK PARK
ORANGEBURG NY 10962-1376
K121390 NURSE ASSIST, INC. 4409 Haltom Rd
Haltom City TX 76117
K141028 PEDIATRIC PHARMACEUTICALS INC. 2137 ROUTE 35
HOLMDEL NJ 07733
K131617 PEDIATRIC PHARMACEUTICALS, INC. 2137 ROUTE 35
HOLMDEL NJ 07733
K961222 PHARMACEUTICAL INNOVATIONS, INC. 1575 EYE STREET, N.W.
WASHINGTON DC 20005
K973557 QUALIS, INC. 4600 PARK AVE.
DES MOINES IA 50321
K073684 SHEFFIELD INDUSTRIES, DIV. OF FARIA LTD. 170 BROAD ST.
NEW LONDON CT 06320
K142473 SION BIOTEXT MEDICAL LTD KIBBUTZ HAGOSHRIM
UPPER GALILEE 12225
K961502 SPAN-AMERICA MEDICAL SYSTEMS, INC. 70 COMMERCE DR.
GREENVILLE SC 29615
K080042 SPIRUS MEDICAL, INC. 5 WHITCOMB AVENUE
AYER MA 01432
K042563 SSL AMERICAS, INC. 3585 ENGINEERING DR.
NORCROSS GA 30092
K101522 ULTRA SEAL CORPORATION 521 MAIN STREET
NEW PALTZ NY 12561




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