510(k) K914932
K914932 is an FDA 510(k) premarket notification submitted by Westmark Hospital Supplies for the device "SUTURE REMOVAL KIT". The FDA issued a decision of Substantially Equivalent (kit) on January 31, 1992. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Westmark Hospital Supplies has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- January 31, 1992
- Date Received
- November 4, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wrap, Sterilization
- Device Class
- Class II
- Regulation Number
- 880.6850
- Review Panel
- HO
- Submission Type