510(k) K790742
K790742 is an FDA 510(k) premarket notification submitted by Pausch Corp. for the device "KS-78 VERTICAL WALL CASSETTE HOLDER". The FDA issued a decision of Substantially Equivalent on April 26, 1979. The device falls under product code IXY (Holder, Radiographic Cassette, Wall-Mounted), a Class I device regulated under 21 CFR 892.1880. Pausch Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 1979
- Date Received
- April 16, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Radiographic Cassette, Wall-Mounted
- Device Class
- Class I
- Regulation Number
- 892.1880
- Review Panel
- RA
- Submission Type