510(k) K875324
K875324 is an FDA 510(k) premarket notification submitted by Schneider-Shilley (Usa) for the device "MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES". The FDA issued a decision of Substantially Equivalent on March 25, 1988. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Schneider-Shilley (Usa) has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 1988
- Date Received
- December 29, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injector And Syringe, Angiographic
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- HO
- Submission Type