Medical Device Manufacturer · US , North Attleboro , MA

Sooil Development Co., Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2000

Recent clearances: DANA 3CC SYRINGE INSULIN RESERVOIR, DANA DIABECARE IIS, DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS

View 4 510(k) Devices ↓
4
Total
4
Cleared
0
Denied

FDA 510(k) Regulatory Record - Sooil Development Co., Ltd. General Hospital ✕

4 devices
1-4 of 4
Cleared Sep 04, 2007
DANA 3CC SYRINGE INSULIN RESERVOIR
K071418 · MRZ
General Hospital · 105d
Cleared Feb 02, 2007
DANA DIABECARE IIS
K063126 · LZG
General Hospital · 112d
Cleared Aug 02, 2002
DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, &...
K022317 · LZG
General Hospital · 16d
Cleared Aug 14, 2000
DANA DIABECARE
K001604 · LZG
General Hospital · 82d
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