510(k) K802761
K802761 is an FDA 510(k) premarket notification submitted by American Hospital Supply Corp. for the device "LATEX PENROSE TUBING CAT. #20400,414,416". The FDA issued a decision of Substantially Equivalent on November 19, 1980. The device falls under product code GAZ (Tubing, Noninvasive), a Class II device regulated under 21 CFR 880.6740. American Hospital Supply Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 1980
- Date Received
- November 4, 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