510(k) K944509
K944509 is an FDA 510(k) premarket notification submitted by Dexide, Inc. for the device "DEXIDE INSUFFLATION TUBING WITH FILTER". The FDA issued a decision of Substantially Equivalent on February 7, 1995. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Dexide, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1995
- Date Received
- September 15, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Laparoscopic
- Device Class
- Class II
- Regulation Number
- 884.1730
- Review Panel
- OB
- Submission Type