510(k) K963601
K963601 is an FDA 510(k) premarket notification submitted by G. Dundas Co. for the device "MODEL 1920 WASTE GAS SCAVENGER". The FDA issued a decision of Substantially Equivalent on April 28, 1997. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. G. Dundas Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 1997
- Date Received
- September 9, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Gas-Scavenging
- Device Class
- Class II
- Regulation Number
- 868.5430
- Review Panel
- AN
- Submission Type