510(k) K001716
K001716 is an FDA 510(k) premarket notification submitted by Pfm Produkte Fur Die Medizin AG for the device "REDON SET". The FDA issued a decision of Substantially Equivalent on July 19, 2000. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Pfm Produkte Fur Die Medizin AG has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2000
- Date Received
- June 5, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type