FDA 510(k) Applications for Medical Device:
Microtools, Assisted Reproduction (Pipettes)

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K024302 BRINKMANN INSTRUMENTS, INC. 49 PLAIN ST.
NORTH ATTLEBORO MA 02760
K991104 CONCEPTION TECHNOLOGY, INC. 3722 AVE. SAUSALITO
IRVINE CA 92606
K151018 COOK INCORPORATED 750 DANIELS WAY
BLOOMINGTON IN 47404
K150748 COOK INCORPORATED 750 DANIELS WAY
BLOOMINGTON IN 47404
K983596 COOK OB/GYN 1100 WEST MORGAN ST.
SPENCER IN 47460
K033903 COOK UROLOGICAL, INC. 1100 WEST MORGAN ST.
SPENCER IN 47460
K033904 COOK UROLOGICAL, INC. 1100 WEST MORGAN ST.
SPENCER IN 47460
K250838 Guangzhou PINZHI Medical Device Co., Ltd. Room 405, 4th Floor, No.600-2 Guangshan 2nd Road
Guangzhou 510520
K012811 HUMAGEN FERTILITY DIAGNOSTICS, INC. 2400 HUNTER'S WAY
CHARLOTTESVILLE VA 22911
K990847 HUMAGEN FERTILITY DIAGNOSTICS, INC. 2400 HUNTER'S WAY
CHARLOTTESVILLE VA 22911
K001615 HUNTER SCIENTIFIC LIMITED UNIT 1, PRIORS HALL,
SAFFRON WALDEN, ESSEX CB113SB
K041562 IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST.
SANTA ANA CA 92705
K102480 JIEYING LABORATORY INC. 9722 AVE. SAUSALITO
IRVINE CA 92606
K152581 LifeGlobal Group, LLC 393 Soundview Road
Guilford CT 06437
K993699 MID-ATLANTIC DIAGNOSTICS, INC. 338 STOKES RD.
MEDFORD NJ 08055
K041435 MID-ATLANTIC DIAGNOSTICS, INC. 438 NORTH ELMWOOD RD.
MARLTON NJ 08053
K991388 PACIFIC ANDROLOGY, INC. 3722 AVE. SAUSALITO
IRVINE CA 92606
K983713 PRODIMED 23 WELISEWITZ RD.
RINGOES NJ 08551
K161275 RESEARCH INSTRUMENTS LIMITED BICKLAND INDUSTRIAL PARK
FALMOUTH TR11 4TA
K133257 RESEARCH INSTRUMENTS LTD. BICKLAND WATER INDUSTRIAL PARK
CORNWALL TR 11 4TA
K991261 RESEARCH INSTRUMENTS LTD. KERNICK RD.
PENRYN, CORWALL TR 10 9DQ
K092554 SUNLIGHT MEDICAL, INC. 12443 SAN JOSE BLVD.
JACKSONVILLE FL 32223
K072600 SUNLIGHT MEDICAL, INC. 12443 SAN JOSE BLVD.
JACKSONVILLE FL 32223
K022643 SWEMED LAB INTERNATIONAL AB 555 13TH ST. N.W.
WASHINGTON DC 20004
K991700 SWEMED LAB INTERNATIONAL AB BILLDALSVAGEN 2
BILLDAL SE-427 36
K192146 Vitromed GmbH Hans-Kn÷ll-Str. 6
Jena 07745




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