510(k) K052633
K052633 is an FDA 510(k) premarket notification submitted by Nemoto Kyorindo Co., Ltd. for the device "DUAL SHOT - CONTRAST DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on October 17, 2005. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Nemoto Kyorindo Co., Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 2005
- Date Received
- September 26, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Injector And Syringe, Angiographic
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- HO
- Submission Type