510(k) K792037
K792037 is an FDA 510(k) premarket notification submitted by Labarge, Inc. for the device "NON-A-THERM". The FDA issued a decision of Substantially Equivalent on November 13, 1979. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Labarge, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 1979
- Date Received
- October 11, 1979
- 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