510(k) K963993
K963993 is an FDA 510(k) premarket notification submitted by Rusch, Inc. for the device "RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET". The FDA issued a decision of Substantially Equivalent on December 17, 1996. 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. Rusch, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 1996
- Date Received
- October 4, 1996
- 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