510(k) K802850
K802850 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL O.R. TOURNIQUET COVER". The FDA issued a decision of Substantially Equivalent on January 13, 1981. The device falls under product code EYR (Tourniquet, Gastro-Urology), a Class I device regulated under 21 CFR 878.5900. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 1981
- Date Received
- November 12, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tourniquet, Gastro-Urology
- Device Class
- Class I
- Regulation Number
- 878.5900
- Review Panel
- SU
- Submission Type