510(k) K880506
K880506 is an FDA 510(k) premarket notification submitted by Gil-Med Industries C/O Kegan & Kegan, Ltd. for the device "MODIFIED EVA-MIX AND DI-MIX BAGS". The FDA issued a decision of Substantially Equivalent on May 20, 1988. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Gil-Med Industries C/O Kegan & Kegan, Ltd. has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 1988
- Date Received
- Feb 8, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Container, I.V.
- Device Class
- Class II
- Regulation Number
- 880.5025
- Review Panel
- HO
- Submission Type
- 510(k)