510(k) K926261
K926261 is an FDA 510(k) premarket notification submitted by Jpi, Inc. for the device "JPI ALUMINUM INTERSPACED X-RAY GRID". The FDA issued a decision of Substantially Equivalent on March 18, 1993. The device falls under product code IXJ (Grid, Radiographic), a Class I device regulated under 21 CFR 892.1910. Jpi, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 1993
- Date Received
- December 18, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Grid, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1910
- Review Panel
- RA
- Submission Type