510(k) K901255
- Device
- Cuff Baro Guard Or Cbg Abbreviated
- Applicant
- NELSON ENGINEERING, INC.
- 510(k) number
- K901255
- Product code
- BSK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-03-28
- Date received
- 1990-03-15
- Regulation
- 868.5750
- Classification name
- Cuff, Tracheal Tube, Inflatable
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- NELSON KALKREUTH
- Address
- 1681 Rt 80 Guilford CT US 06437 06437
FDA Registration Numbers#
- 3029906224
- 3007014520
- 3042254935
- 2031966
- 2182318
- 3012072872
- 2518436
- 3007740622
- 3007048256
- 2022648
- 9616567
- 3014766741
- 3009959868
- 1221763
- 1056553
- 8010485
- 3007682555
- 3014254831
- 3011481350
- 3009050824
- 3016548968
- 3043543260
- 3010806663
- 3018226067
- 3004992992
- 8010939
- 3009307931
- 1417592
- 2951529
- 3003935342
- 3006024395
- 3006673317
- 1047843
- 3018094310
- 3009973505
- 3010326740
- 3005803389
- 3012307300
- 3011137372
- 3016438694
- 3007713076
- 3030412764
- 2936999
- 3004593495
- 1314417
- 3004365956
Source Documents#
510(k) summary PDF not indicated by FDA
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