510(k) K030032
K030032 is an FDA 510(k) premarket notification submitted by Omrix Biopharmaceuticals, Inc. for the device "CROSSEAL APPLICATION DEVICE". The FDA issued a decision of Substantially Equivalent on Mar 21, 2003. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Omrix Biopharmaceuticals, Inc. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 21, 2003
- Date Received
- Jan 3, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Needle, Hypodermic, Single Lumen
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type
- 510(k)