510(k) K972655
K972655 is an FDA 510(k) premarket notification submitted by Medical Specialties Intl., Inc. for the device "CONTROL SYRINGE". The FDA issued a decision of Substantially Equivalent on November 4, 1997. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Medical Specialties Intl., Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 1997
- Date Received
- July 15, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Angiographic
- Device Class
- Class II
- Regulation Number
- 892.1600
- Review Panel
- RA
- Submission Type