FDA 510(k) Applications Submitted by Maureen Garner
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K130082 |
01/14/2013 |
GENPRIME DRUGS OF ABUSE READER SYSTEM |
GENPRIME, INC |
| K961712 |
05/02/1996 |
TBD AT-HOME PREGNANCY TEST |
ARMKEL, LLC. |
| K131306 |
05/07/2013 |
IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE |
BIO COMPRESSION SYSTEMS, INC. |
| K131327 |
05/08/2013 |
BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM |
BIO COMPRESSION SYSTEMS, INC. |
| K962183 |
06/06/1996 |
BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES |
ARMKEL, LLC. |
| K011855 |
06/13/2001 |
WAMPOLE HS-CRP ELISA |
CARTER-WALLACE, INC. |
| K992232 |
07/02/1999 |
FIRST RESPONSE 1-STEP PREGNANCY |
ARMKEL, LLC. |
| K122112 |
07/17/2012 |
2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM |
BIO COMPRESSION SYSTEMS, INC. |
| K103298 |
11/08/2010 |
ACAM 5 AUDIOMETER SYSTEM |
ACOUSTICON GMBH |
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