510(k) K021983
K021983 is an FDA 510(k) premarket notification submitted by Ultimed, Inc. for the device "ULTI GUARD HOME INSULIN SYRINGE CONTAINER". The FDA issued a decision of Substantially Equivalent on Sep 16, 2002. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Ultimed, Inc. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 16, 2002
- Date Received
- Jun 18, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Sharps
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type
- 510(k)