510(k) K780735
K780735 is an FDA 510(k) premarket notification submitted by Shield Laboratories, Inc. for the device "URINARY CATHETER CARE SET". The FDA issued a decision of Substantially Equivalent on June 13, 1978. 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. Shield Laboratories, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 1978
- Date Received
- May 1, 1978
- 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