510(k) K860265
K860265 is an FDA 510(k) premarket notification submitted by R. J. Ltd., Ind. for the device "TELESCOPE PROTECTION TUBE". The FDA issued a decision of Substantially Equivalent on April 7, 1986. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. R. J. Ltd., Ind. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 1986
- Date Received
- January 27, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Urological
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type