510(k) K832519
K832519 is an FDA 510(k) premarket notification submitted by Wells Johnson Co. for the device "ASPIRATING TUBING". The FDA issued a decision of Substantially Equivalent on October 20, 1983. The device falls under product code GAZ (Tubing, Noninvasive), a Class II device regulated under 21 CFR 880.6740. Wells Johnson Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1983
- Date Received
- August 8, 1983
- 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