510(k) K790340
K790340 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "DELTA-ROL". The FDA issued a decision of Substantially Equivalent on April 12, 1979. The device falls under product code GCO (Endoscope, Mirror), a Class II device regulated under 21 CFR 876.1500. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 1979
- Date Received
- February 21, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope, Mirror
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type