510(k) K041232
K041232 is an FDA 510(k) premarket notification submitted by Gettig Pharmaceutical Instrument Co. for the device "GETTIG UNIVERSAL VIAL ACCESS PIN". The FDA issued a decision of Substantially Equivalent on July 22, 2004. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Gettig Pharmaceutical Instrument Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2004
- Date Received
- May 10, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, I.V. Fluid Transfer
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type