510(k) K760927
K760927 is an FDA 510(k) premarket notification submitted by Rudolfo T. Sanchez for the device "STOMA SHIELD ADAPTER". The FDA issued a decision of Substantially Equivalent on January 26, 1977. The device falls under product code EXE (Protector, Ostomy), a Class I device regulated under 21 CFR 876.5900.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1977
- Date Received
- October 28, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protector, Ostomy
- Device Class
- Class I
- Regulation Number
- 876.5900
- Review Panel
- GU
- Submission Type