510(k) K913602
K913602 is an FDA 510(k) premarket notification submitted by Ideal Medical, Inc. for the device "IDEAS' PORT". The FDA issued a decision of Substantially Equivalent (kit) on January 2, 1992. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Ideal Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- January 2, 1992
- Date Received
- August 13, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type