510(k) K960082
K960082 is an FDA 510(k) premarket notification submitted by Spinal Specialties, Inc. for the device "DISCOGRAPHY KIT". The FDA issued a decision of Substantially Equivalent on March 21, 1996. The device falls under product code IZG (System, X-Ray, Photofluorographic), a Class II device regulated under 21 CFR 892.1730. Spinal Specialties, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 1996
- Date Received
- January 11, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Photofluorographic
- Device Class
- Class II
- Regulation Number
- 892.1730
- Review Panel
- RA
- Submission Type