510(k) K914934
K914934 is an FDA 510(k) premarket notification submitted by Westmark Hospital Supplies for the device "HAND PACK". The FDA issued a decision of Substantially Equivalent (kit) on January 21, 1993. The device falls under product code KDO (Rongeur, Cystoscopic, Hot), a Class II device regulated under 21 CFR 876.1500. Westmark Hospital Supplies has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- January 21, 1993
- Date Received
- November 4, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rongeur, Cystoscopic, Hot
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type