510(k) K894405
K894405 is an FDA 510(k) premarket notification submitted by Irvine Scientific for the device "HTF WITH ALBUMIN (CATALOG NO. 9994)". The FDA issued a decision of Substantially Equivalent on September 22, 1989. The device falls under product code HDR (Cap, Cervical), a Class II device regulated under 21 CFR 884.5250. Irvine Scientific has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 1989
- Date Received
- July 17, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cap, Cervical
- Device Class
- Class II
- Regulation Number
- 884.5250
- Review Panel
- OB
- Submission Type