510(k) K821313
K821313 is an FDA 510(k) premarket notification submitted by Megaplast, Inc. for the device "SURGICAL UTILITY DRAPE". The FDA issued a decision of Substantially Equivalent on June 21, 1982. The device falls under product code FJZ (Declotting Tray, Kit (Including Contents)), a Class II device regulated under 21 CFR 876.5820. Megaplast, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 1982
- Date Received
- May 4, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Declotting Tray, Kit (Including Contents)
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type