FDA 510(k) Applications Submitted by DAVID L ROSEN, B.S. PHARM., J.D.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K230358 |
02/10/2023 |
SAVI Dual (TM) Migraine Therapy |
eNeura, Inc. |
| K052818 |
10/04/2005 |
EZ SMART-168 GLUCOSE MONITORING SYSTEM |
TYSON BIORESEARCH, INC. |
| K182976 |
10/26/2018 |
SpringTMS |
eNeura« Inc. |
| K980952 |
03/13/1998 |
SNORE-CURE ANTI-SNORING APPLIANCE |
ORTHO-TAIN, INC. |
| K040848 |
04/01/2004 |
EZ SMART |
VIP INTERNATIONAL WHOLESALERS, CORP. |
| K031809 |
06/12/2003 |
PERIO PROTECT TRAY |
PERIO PROTECT LLC |
| K082689 |
09/15/2008 |
STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE |
SPECTRA MEDICAL DEVICES, INC. |
| K043340 |
12/03/2004 |
EZ SMART |
VIP DIAGNOSTICS LLC |
| K103740 |
12/22/2010 |
SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE |
SPECTRA MEDICAL DEVICES, INC. |
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