510(k) K791146
K791146 is an FDA 510(k) premarket notification submitted by Suburban Ostomy Supply Co., Inc. for the device "COLO-TAPE". The FDA issued a decision of Substantially Equivalent on July 30, 1979. The device falls under product code EZR (Cement, Stomal Appliance, Ostomy), a Class I device regulated under 21 CFR 876.5900.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 1979
- Date Received
- June 18, 1979
- 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