510(k) K802777
K802777 is an FDA 510(k) premarket notification submitted by Sherwood Medical Co. for the device "ARGYLE CONNECT TUBE-CON & NON". The FDA issued a decision of Substantially Equivalent on December 11, 1980. The device falls under product code GAZ (Tubing, Noninvasive), a Class II device regulated under 21 CFR 880.6740. Sherwood Medical Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 1980
- Date Received
- November 5, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Noninvasive
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type