510(k) K894787
K894787 is an FDA 510(k) premarket notification submitted by New York Blood Center, Inc. for the device "MEL-PAK GENERAL DRUG DELIVERY SYSTEM KIT". The FDA issued a decision of Substantially Equivalent on Sep 13, 1989. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 13, 1989
- Date Received
- Jul 31, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
- 510(k)