510(k) K924541
K924541 is an FDA 510(k) premarket notification submitted by Concord/Portex for the device "EPIDURAL MINIPACK". The FDA issued a decision of Substantially Equivalent (kit) on July 9, 1993. The device falls under product code BYO (Bottle, Blow), a Class I device regulated under 21 CFR 868.5220. Concord/Portex has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- July 9, 1993
- Date Received
- September 8, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bottle, Blow
- Device Class
- Class I
- Regulation Number
- 868.5220
- Review Panel
- AN
- Submission Type