510(k) K030664
K030664 is an FDA 510(k) premarket notification submitted by Amsino International, Inc. for the device "AMSURE FOLEY INSERTION TRAY". The FDA issued a decision of Substantially Equivalent on May 23, 2003. The device falls under product code FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)), a Class II device regulated under 21 CFR 876.5130. Amsino International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2003
- Date Received
- March 3, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type