510(k) K941011
K941011 is an FDA 510(k) premarket notification submitted by Applied Medical Resources for the device "ACU-SIZER(TM)". The FDA issued a decision of Substantially Equivalent on June 13, 1994. The device falls under product code EYB (Catheter, Ureteral, Gastro-Urology), a Class II device regulated under 21 CFR 876.5130. Applied Medical Resources has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 1994
- Date Received
- March 3, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Ureteral, Gastro-Urology
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type