510(k) K772402
K772402 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "QUADRIPLEGIC URINARY DRAINAGE VALVE". The FDA issued a decision of Substantially Equivalent on January 26, 1978. The device falls under product code FAQ (Bag, Urine Collection, Leg, For External Use, Sterile), a Class I device regulated under 21 CFR 876.5250. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1978
- Date Received
- December 27, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bag, Urine Collection, Leg, For External Use, Sterile
- Device Class
- Class I
- Regulation Number
- 876.5250
- Review Panel
- GU
- Submission Type