510(k) K792109
K792109 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR LATEX FOLEY CATH-STERILE". The FDA issued a decision of Substantially Equivalent on Nov 16, 1979. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Conphar, Inc. has 121 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 16, 1979
- Date Received
- Oct 25, 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
- 510(k)