510(k) K792494
K792494 is an FDA 510(k) premarket notification submitted by C. Intl. for the device "CATHETERIZATION FORCEP". The FDA issued a decision of Substantially Equivalent on December 20, 1979. The device falls under product code GEN (Forceps, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. C. Intl. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 1979
- Date Received
- December 4, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type