510(k) K011283
- Device
- MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE
- Applicant
- THE KENDALL COMPANY
- 510(k) number
- K011283
- Product code
- NGT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-10-15
- Date received
- 2001-04-27
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID A OLSON
- Address
- 15 Hampshire St. Mansfield MA US 02048 02048
FDA Registration Numbers#
- 3038181770
- 1911916
- 3017509841
- 3005669815
- 3007590959
- 3016413378
- 3007163376
- 3008518459
- 1043214
- 2320762
- 3034669683
- 1423662
- 3004756837
- 3005806438
- 1423982
- 1055236
- 3016741564
- 3015060216
- 3016707060
- 3025432964
- 1417592
- 3004080548
- 3015751263
- 1057300
- 9680794
- 2243072
- 3011508621
- 3009848807
- 3043709866
- 1650927
- 3014421917
- 1047843
- 3036706541
- 3002907620
- 1649518
- 1224960
- 2027791
- 3010405396
- 3016761372
- 3012494290
- 3012421607
- 3036113190
- 3002682307
- 1054241
- 3020460367
- 3005934752
- 1526711
- 2518902
- 9616657
- 3036757319
- 1423507
- 3010882708
Source Documents#
Legacy Summary#
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FDA Review#
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