510(k) K852331
K852331 is an FDA 510(k) premarket notification submitted by Scholten Surgical Instruments, Inc. for the device "SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC". The FDA issued a decision of Substantially Equivalent on August 1, 1986. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Scholten Surgical Instruments, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 1986
- Date Received
- May 31, 1985
- 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