FDA 510(k) Applications Submitted by LAKE REGION MFG., INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K080144 |
01/22/2008 |
MANDREL GUIDEWIRES OR M-WIRES |
LAKE REGION MFG., INC. |
| K081708 |
06/17/2008 |
TAXI ENDOSCOPIC GUIDEWIRE |
LAKE REGION MFG., INC. |
| K082922 |
10/01/2008 |
FREEWAY AND RAILRUNNER GUIDEWIRES |
LAKE REGION MFG., INC. |
| K011968 |
06/25/2001 |
STREERABLE PTCA GUIDEWIRE |
LAKE REGION MFG., INC. |
| K000011 |
01/03/2000 |
MODIFIED HYDROPHILIC COATED GUIDEWIRE |
LAKE REGION MFG., INC. |
| K011084 |
04/10/2001 |
MANDREL GUIDEWIRE ASSEMBLY |
LAKE REGION MFG., INC. |
| K003483 |
11/09/2000 |
MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE) |
LAKE REGION MFG., INC. |
| K060454 |
02/22/2006 |
TITAN GUIDEWIRE |
LAKE REGION MFG., INC. |
| K040825 |
03/30/2004 |
LAKE REGION HYDROPHILIC GUIDEWIRE |
LAKE REGION MFG., INC. |
| K041624 |
06/16/2004 |
PTCA STEERABLE HYDROPHILIC GUIDEWIRE |
LAKE REGION MFG., INC. |
| K022813 |
08/26/2002 |
STEERABLE GUIDEWIRE |
LAKE REGION MFG., INC. |
| K052347 |
08/29/2005 |
TITAN STEERABLE (PTCA) GUIDEWIRE |
LAKE REGION MFG., INC. |
| K042338 |
08/30/2004 |
CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE |
LAKE REGION MFG., INC. |
| K092965 |
09/25/2009 |
TRAILRUNNER GUIDEWIRES |
LAKE REGION MFG., INC. |
| K033758 |
12/02/2003 |
HYDROPHILIC GUIDEWIRE |
LAKE REGION MFG., INC. |
| K073655 |
12/26/2007 |
PEGASUS STEERABLE (PTCA) GUIDEWIRE |
LAKE REGION MFG., INC. |
| 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. |
| 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. |
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