510(k) K920421
K920421 is an FDA 510(k) premarket notification submitted by Medsurg Industries, Inc. for the device "MEDSURG MARSHMALLOW TRAY". The FDA issued a decision of Substantially Equivalent (kit) on December 13, 1993. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Medsurg Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- December 13, 1993
- Date Received
- January 31, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Device Class
- Class II
- Regulation Number
- 878.5000
- Review Panel
- SU
- Submission Type