510(k) K890436
K890436 is an FDA 510(k) premarket notification submitted by Teknomed, Inc. for the device "TECHNOMED PULSOLITH LASER SYSTEM". The FDA issued a decision of Substantially Equivalent on March 23, 1989. The device falls under product code FFK (Lithotriptor, Electro-Hydraulic), a Class II device regulated under 21 CFR 876.4480. Teknomed, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1989
- Date Received
- January 27, 1989
- 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