510(k) K960082
- Device
- DISCOGRAPHY KIT
- Applicant
- SPINAL SPECIALTIES, INC.
- 510(k) number
- K960082
- Product code
- IZG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-03-21
- Date received
- 1996-01-11
- Regulation
- 892.1730
- Classification name
- System, X-ray, Photofluorographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL WAKELY
- Address
- 4230 Centergate San Antonio TX US 78217 78217
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IZG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960146 | G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY | GE Medical Systems | 1996-02-27 |
| K913436 | PXI PNEUMATIC COMPRESSION PADDLE | Brotherston/Pxi | 1992-11-05 |
| K920393 | MU125M MOBILE X-RAY SYSTEM | Shimadzu Medical Systems | 1992-04-06 |
| K910503 | DISCOGRAPHY KIT | B. Braun of America, Inc. | 1991-10-07 |
| K903808 | AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT | Advanced Med/Surg, Inc. | 1991-01-22 |
| K892659 | ELECTRODELCA | Oldelft Corp. of America | 1989-11-21 |
Legacy Summary#
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FDA Review#
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