510(k) K101547
K101547 is an FDA 510(k) premarket notification submitted by Henke-Sass, Wolf GmbH for the device "HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)". The FDA issued a decision of Substantially Equivalent on November 22, 2010. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Henke-Sass, Wolf GmbH has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2010
- Date Received
- June 3, 2010
- 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