510(k) K924128
K924128 is an FDA 510(k) premarket notification submitted by Applied Medical Resources for the device "CHOLANGIOGRAPHY CATHETER". The FDA issued a decision of Substantially Equivalent on February 10, 1993. The device falls under product code GBZ (Catheter, Cholangiography), a Class I device regulated under 21 CFR 878.4200. Applied Medical Resources has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1993
- Date Received
- August 17, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Cholangiography
- Device Class
- Class I
- Regulation Number
- 878.4200
- Review Panel
- SU
- Submission Type