510(k) K875324

MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES by Schneider-Shilley (Usa) — Product Code DXT

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