FDA 510(k) Applications for Medical Device:
Warmer, Irrigation Solution

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K051819 C CHANGE SURGICAL LLC 101 NORTH CHESTNUT STREET
WINSTON-SALEM NC 27101
K083417 C CHANGE SURGICAL LLC 101 NORTH CHESTNUT STREET
WINSTON-SALEM NC 27101
K150190 Ecolab Inc. 370 Wabasha Street North
St. Paul MN 55102-1390
K142080 ECOLAB, INC. 370 WABASHA STREET NORTH
ST.PAUL MN 55102
K142173 ECOLAB, INC. 370 WABASHA STREET NORTH
ST.PAUL MN 55102
K152522 ECOLAB, INC. 370 WABASHA STREET NORTH
SAINT PAUL MN 55102
K153713 GETINGE SOURCING, LLC 1777 EAST HENRIETTA ROAD
ROCHESTER NY 14623
K002859 KMI KOLSTER METHODS, INC. 708 NORTH VALLEY, SUITE N
ANAHEIM CA 92801
K080609 MAC MEDICAL PO BOX 7007
DEERFIELD IL 60015
K023283 O.R. SOLUTIONS, INC. 3901 CENTERVIEW DR.
CHANTILLY VA 20151-1689
K021288 O.R. SOLUTIONS, INC. 3901 CENTERVIEW DR.
CHANTILLY VA 20151-1689
K023282 O.R. SOLUTIONS, INC. 3901 CENTERVIEW DR.
CHANTILLY VA 20151-1689
K021289 O.R. SOLUTIONS, INC. 3901 CENTERVIEW DR.
CHANTILLY VA 20151-1689
K971117 OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH
SEATTLE WA 98108
K965136 PRINCETON REGULATORY ASSOC. 116 VILLAGE BLVD., SUITE 200
PRINCETON NJ 08540-5799




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