510(k) K761099
K761099 is an FDA 510(k) premarket notification submitted by Will Ross Co. for the device "DOVER HYPERALIMENTATION DRESSING CHNG KT". The FDA issued a decision of Substantially Equivalent on January 28, 1977. The device falls under product code FRL (Fiber, Medical, Absorbent), a Class I device regulated under 21 CFR 880.5300. Will Ross Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 1977
- Date Received
- November 22, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fiber, Medical, Absorbent
- Device Class
- Class I
- Regulation Number
- 880.5300
- Review Panel
- HO
- Submission Type