510(k) K790856
K790856 is an FDA 510(k) premarket notification submitted by C. Intl. for the device "PROCTOSCOPE #501". The FDA issued a decision of Substantially Equivalent on May 29, 1979. The device falls under product code GCF (Proctoscope), a Class II device regulated under 21 CFR 876.1500. C. Intl. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 1979
- Date Received
- May 4, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Proctoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type