FDA 510(k) Applications Submitted by Michelle Schiltz-Taing
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180824 |
03/30/2018 |
VaPro 2 Intermittent Catheter |
Hollister Incorporated |
| K211436 |
05/10/2021 |
Intermittent Catheter (Not Finalized) |
Hollister Incorporated |
| K141439 |
06/02/2014 |
ORTHODONTIC ACRYLIC (NOT FINALIZED) |
BISCO, INC. |
| K091705 |
06/10/2009 |
PRIMER PLUS |
BISCO, INC. |
| K131734 |
06/13/2013 |
ALL-BOND UNIVERSAL SC (NOT FINALIZED) |
BISCO, INC. |
| K191633 |
06/19/2019 |
Infyna Chic |
Hollister Incorporated |
| K101787 |
06/25/2010 |
DUOLINK II |
BISCO, INC. |
| K112118 |
07/25/2011 |
DREAMBOND |
BISCO, INC. |
| K082449 |
08/25/2008 |
BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 |
BISCO, INC. |
| K102844 |
09/29/2010 |
ALL-BOUND 3 |
BISCO, INC. |
| K233524 |
11/01/2023 |
Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) |
Hollister Incorporated |
| K093470 |
11/06/2009 |
CORE-FLO D/C |
BISCO, INC. |
| K213575 |
11/10/2021 |
Female IC (Not Finalized) |
Hollister Incorporated |
| K193148 |
11/13/2019 |
VaPro Plus Pocket, VaPro Plus |
Hollister Incorporated |
| K113401 |
11/17/2011 |
ORTHO-1(NOT FINALIZED) |
BISCO, INC. |
| K143292 |
11/17/2014 |
TheraCal DC |
Bisco Inc |
| K183253 |
11/21/2018 |
ValPro 2 Plus, VaPro 2 Plus Pocket |
Hollister Incorporated |
| K123653 |
11/27/2012 |
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED) |
BISCO, INC. |
| K103514 |
11/30/2010 |
PRO-V COAT |
BISCO, INC. |
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