510(k) K770230
K770230 is an FDA 510(k) premarket notification submitted by Atlantic Surgical for the device "KARAYA GUM POWDER". The FDA issued a decision of Substantially Equivalent on February 28, 1977. The device falls under product code EZR (Cement, Stomal Appliance, Ostomy), a Class I device regulated under 21 CFR 876.5900. Atlantic Surgical has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1977
- Date Received
- February 7, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Stomal Appliance, Ostomy
- Device Class
- Class I
- Regulation Number
- 876.5900
- Review Panel
- GU
- Submission Type