510(k) K022495
K022495 is an FDA 510(k) premarket notification submitted by Gettig Pharmaceutical Instrument Co. for the device "GETTIG DISPOSABLE SYRINGES". The FDA issued a decision of Substantially Equivalent on October 8, 2002. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Gettig Pharmaceutical Instrument Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2002
- Date Received
- July 29, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type