510(k) K962254
K962254 is an FDA 510(k) premarket notification submitted by National Healthcare Mfg. Corp. for the device "NHMC URETHRAL CATHETERIZATION TRAY". The FDA issued a decision of Substantially Equivalent on July 29, 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. National Healthcare Mfg. Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 1996
- Date Received
- June 12, 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