510(k) K191378
- Device
- 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe
- Applicant
- Medline Industries, Inc.
- 510(k) number
- K191378
- Product code
- NGT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-09-15
- Date received
- 2019-05-23
- Regulation
- 880.5200
- Classification name
- Saline, Vascular Access Flush
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Stephanie Augsburg
- Address
- Three Lake Dr. Northfiled IL US 60093 60093
FDA Registration Numbers#
- 1526711
- 3012421607
- 3025432964
- 9680794
- 3036706541
- 3036113190
- 3015060216
- 3004756837
- 1417592
- 3011508621
- 3016707060
- 1649518
- 3017509841
- 2027791
- 3002682307
- 2243072
- 3012494290
- 1423982
- 3007163376
- 1423662
- 3004080548
- 3016413378
- 3009848807
- 3043709866
- 1650927
- 9616657
- 3005806438
- 3007590959
- 3005934752
- 3016761372
- 3005669815
- 3036757319
- 3010882708
- 3015751263
- 3038181770
- 1911916
- 3014421917
- 3002907620
- 3016741564
- 1423507
- 1054241
- 1224960
- 2518902
- 3020460367
- 1057300
- 1043214
- 1055236
- 2320762
- 3034669683
- 3010405396
- 1047843
- 3008518459
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases