FDA 510(k) Applications Submitted by PENNY NORTHCUTT
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120182 |
01/20/2012 |
NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES |
NEOMED, INC. |
| K100288 |
02/01/2010 |
NEOMED ENTERAL ONLY EXTENSION SET |
NEOMED, INC. |
| K030350 |
02/03/2003 |
EXPRESS MINI GLAUCOMA SHUNT |
OPTONOL, LTD |
| K111458 |
05/26/2011 |
GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS |
GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. |
| K081515 |
05/30/2008 |
NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 |
NEOMED, INC. |
| K031735 |
06/04/2003 |
CENTURION SES EPIKERATOME |
CIBA VISION CORPORATION |
| K091958 |
07/01/2009 |
BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM |
GLENVEIGH SURGICAL, LLC |
| K122219 |
07/25/2012 |
THEYFIT MALE CONDOM |
THEYFIT |
| K122337 |
08/02/2012 |
OVUSENSE |
FERTILITY FOCUS LTD |
| K082238 |
08/07/2008 |
NEOMED POLYURETHANE FEEDING TUBE |
NEOMED, INC. |
| K132561 |
08/15/2013 |
NURO NEUROMODULATION SYSTEM |
ADVANCED URO-SOLUTIONS, INC. |
| K102652 |
09/14/2010 |
NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS |
GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. |
| K092908 |
09/22/2009 |
NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO |
NEOMED, INC. |
| K032978 |
09/24/2003 |
MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME |
CIBA VISION CORPORATION |
| K072881 |
10/09/2007 |
NEOMED Enteral FEEDING TUBE |
NEOMED, INC. |
| K072997 |
10/24/2007 |
NEOMED URINARY CATHETER |
NEOMED, INC. |
| K073596 |
12/21/2007 |
NEOMED SINGLE LUMEN UMBILICAL CATHETER |
NEOMED, INC. |
| K093904 |
12/22/2009 |
GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER |
GLENVEIGH SURGICAL, LLC |
| K050065 |
01/12/2005 |
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES |
CIBA VISION CORPORATION |
| K010189 |
01/22/2001 |
VORTEX ACCESS SYSTEM |
HORIZON MEDICAL PRODUCTS, INC. |
| K010767 |
03/14/2001 |
LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES |
HORIZON MEDICAL PRODUCTS, INC. |
| K011916 |
06/20/2001 |
SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES |
HORIZON MEDICAL PRODUCTS, INC. |
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