FDA 510(k) Applications Submitted by Kim E. Aves
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K970376 |
02/03/1997 |
PTCA GUIDEWIRE |
LAKE REGION MFG., INC. |
| K970994 |
03/19/1997 |
CORE AND COIL ASSEMBLY GUIDEWIRE |
LAKE REGION MFG., INC. |
| K971322 |
04/10/1997 |
CORE AND COIL ASSEMBLY GUIDEWIRE |
LAKE REGION MFG., INC. |
| K031891 |
06/13/2003 |
VIRTUOSAPH |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| K960718 |
02/21/1996 |
LRM |
LAKE REGION MFG., INC. |
| K960866 |
03/04/1996 |
LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS. |
LAKE REGION MFG., INC. |
| K981326 |
04/13/1998 |
LAKE REGION MANUFACTURING GUIDEWIRES |
LAKE REGION MFG., INC. |
| K981667 |
05/11/1998 |
HYDROPHILIC COATED GUIDEWIRE |
LAKE REGION MFG., INC. |
| K041324 |
05/18/2004 |
CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER |
LIFECORE BIOMEDICAL, INC. |
| K192900 |
10/15/2019 |
H500 Multi-Sensing Oximetry System |
Nonin Medical, Inc. |
| K160231 |
02/01/2016 |
Model X-100C CO-MetÖ Oximetry System |
NONIN MEDICAL, INC. |
| K172625 |
09/01/2017 |
Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor |
Nonin Medical Inc. |
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