FDA 510(k) Applications Submitted by LORI K HOLDER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140984 |
04/16/2014 |
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM |
TANGO3, LLC |
| K093641 |
11/24/2009 |
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM |
TANGO3, LLC |
| K970300 |
01/24/1997 |
NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI |
INTERMEDICS ORTHOPEDICS |
| K960281 |
01/19/1996 |
IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY |
INTERMEDICS, INC. |
| K962174 |
06/05/1996 |
BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) |
INTERMEDICS, INC. |
| K972501 |
07/03/1997 |
APOLLO REVISION/CONSTRAINED KNEE SYSTEM |
SULZER ORTHOPEDICS, INC. |
| K972637 |
07/15/1997 |
PRECEDENT REVISION HIP SYSTEM |
SULZER ORTHOPEDICS, INC. |
| K973412 |
09/09/1997 |
NATURAL-KNEE II CONSTRAINED KNEE SYSTEM |
SULZER ORTHOPEDICS, INC. |
| K954719 |
10/13/1995 |
INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD |
INTERMEDICS, INC. |
| K964357 |
11/01/1996 |
NATURAL-HIP SYSTEM COCR STEM |
INTERMEDICS ORTHOPEDICS |
| K955122 |
11/09/1995 |
INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD |
INTERMEDICS, INC. |
| K955550 |
12/05/1995 |
CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD |
INTERMEDICS, INC. |
| K970166 |
01/16/1997 |
NATURAL-HIP SYSTEM COCR REVISION STEM |
INTERMEDICS ORTHOPEDICS |
| K973124 |
08/20/1997 |
APR POROUS HA HIP SYSTEM |
SULZER ORTHOPEDICS, INC. |
| K024076 |
12/10/2002 |
MAKY 21.1 DIALYZER REPROCESSING SYSTEM |
HDC MAQUINOLAS, LLC |
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