510(k) K803012
K803012 is an FDA 510(k) premarket notification submitted by Shur Medical Corp. for the device "SHUR-PATCH TAPE PATCH". The FDA issued a decision of Substantially Equivalent on December 30, 1980. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Shur Medical Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1980
- Date Received
- November 28, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type