510(k) K873435
K873435 is an FDA 510(k) premarket notification submitted by Level 1 Technologies, Inc. for the device "LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET". The FDA issued a decision of Substantially Equivalent on October 5, 1987. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Level 1 Technologies, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 1987
- Date Received
- August 26, 1987
- 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