510(k) K933570
- Device
- RESOLUTION(TM) HIP STEM
- Applicant
- Wrightmedicaltechnologyinc
- 510(k) number
- K933570
- Product code
- LJW
- Decision
- Substantially Equivalent for Some Indications (SN)
- Decision date
- 1994-03-07
- Date received
- 1993-07-23
- Regulation
- 874.4420
- Classification name
- Tracheotome
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Contact
- JUDY ENGLISH
- Address
- 5677 Airline Rd. Arlington TN US 38002 38002
FDA Registration Numbers#
- 3035708926
- 1450662
- 3010536692
- 2245304
- 3005273623
- 8040278
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LJW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K822618 | EMERGENCY TRACHEOSTOMY INSTRUMENT SET | Kelleher Corp. | 1983-01-28 |