510(k) K832521
K832521 is an FDA 510(k) premarket notification submitted by Wells Johnson Co. for the device "PLASTIC SUCTION TIPS". The FDA issued a decision of Substantially Equivalent on October 20, 1983. The device falls under product code GEA (Cannula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. 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
- Cannula, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type