FDA 510(k) Applications for Medical Device:
Attachment, Breathing, Positive End Expiratory Pressure

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K090317 A PLUS MEDICAL 5431 AVENIDA ENCINAS
CARLSBAD CA 92008
K110713 AIRWAYS DEVELOPMENT, LLC P.O. BOX 558
CEDAR KNOLLS NJ 07927
K160112 BESMED HEALTH BUSINESS CORP. NO.5, LANE 116, WU-KONG 2ND RD
NEW TAIPEI CITY
K982283 CARADYNE, LTD. 6329 W. WATERVIEW CT.
MCCORDSVILLE IN 46055
K981415 CHEEN HOUNG ENT. CO. LTD. 23 SAN DREEN ST., ALLEY 11,
TAIPEI (SHULIN) 23805
K092029 DRAEGER MEDICAL AG & CO. KG 3135 Quarry Road
Telford PA 18969
K983920 ENGINEERED MEDICAL SYSTEMS 8529 ZIONSVILLE RD.
INDIANAPOLIS IN 46268
K133957 GALEMED CORP. AMOY EXPORT PROCESSING ZONE, 39
XIAMEN, FUJIAN 361000
K963347 INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD.
BETHEL PARK PA 15102
K050918 KOO AMERICAS, INC. 1050-C NINE NORTH DRIVE
ALPHARETTA GA 30004
K961867 MEDICAL MARKETING CONCEPTS 2310 YORK RD.
ROANOKE VA 24015
K081266 MERCURY ENTERPRIZES DBA MERCURY MEDICAL 11300 49TH STREET NORTH
CLEARWATER FL 33762
K090710 MERCURY MEDICAL 24301 WOODSAGE DRIVE
BONITA SPRINGS FL 34134
K070416 NEOFORCE GROUP, INC. 35 COMMERCE DR.
IVYLAND PA 18974
K103833 NEOFORCE GROUP, INC. 35 COMMERCE DR.
IVYLAND PA 18974
K962492 NIDEK MEDICAL PRODUCTS, INC. 3949 VALLEY EAST INDUSTRIAL DR
BIRMINGHAM AL 35217
K112546 O-TWO MEDICAL TECHNOLOGIES, INC. 7575 KIMBEL ST.
MISSISSAUGA, ONTARIO L5S 1C8
K080256 PULMODYNE 24301 WOODSAGE DRIVE
BONITA SPRINGS FL 33134-2958
K133210 S & T MEDICAL TECHNOLOGIES, INC. 1954 KELLOGG AVENUE
CARLSBAD CA 92008
K122610 SEN MU TECHNOLOGY CO., LTD. NO. 15-2, LANE 26, MINCYUAN 1SR RD
KAOHSIUNG CITY 802
K001318 SIMS PORTEX, INC. 10 BOWMAN DR.
KEENE NH 03431
K013884 VYGON S A 45900 PARSIPPANY COURT
TEMECULA CA 92592
K955047 WESTMED INTL. 3351 EAST HEMISPHERE LOOP
TUCSON AZ 85706




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