510(k) K822644
K822644 is an FDA 510(k) premarket notification submitted by R. Wolf Medical Instruments Corp. for the device "RIWOLITH 2135". The FDA issued a decision of Substantially Equivalent on September 21, 1982. The device falls under product code FFK (Lithotriptor, Electro-Hydraulic), a Class II device regulated under 21 CFR 876.4480. R. Wolf Medical Instruments Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 1982
- Date Received
- September 1, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lithotriptor, Electro-Hydraulic
- Device Class
- Class II
- Regulation Number
- 876.4480
- Review Panel
- GU
- Submission Type