510(k) K883902
K883902 is an FDA 510(k) premarket notification submitted by Kalajian Ent. for the device "INFUSA-PLATE". The FDA issued a decision of Substantially Equivalent on October 27, 1988. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Kalajian Ent. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 1988
- Date Received
- September 15, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type