510(k) K844051
- Device
- Skilcraft - Tracheotomy Care Kit 3 Compartment
- Applicant
- WASHINGTON-GREENE COUNTY BRANCH PENNSYLVANIA ASSOC
- 510(k) number
- K844051
- Product code
- NXA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-01-18
- Date received
- 1984-10-17
- Regulation
- 868.5800
- Classification name
- Tracheotomy Care Kit
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DENNIS R CHARLTON
- Address
- 566 E. Maiden St. Washington PA US 15301 15301
FDA Registration Numbers#
- 3005595283
- 9612030
- 1061124
- 3009203853
- 1928237
- 3026197444
- 3012307300
- 2433012
- 1123010
- 3014257280
- 3015173212
- 3004111573
- 1030451
- 1423395
- 1643817
- 3035642068
- 1423537
- 9616088
- 3004519921
- 3004122598
- 1422634
- 3007329020
- 3009888344
- 3005012805
- 3005460813
Source Documents#
510(k) summary PDF not indicated by FDA