510(k) K890438
K890438 is an FDA 510(k) premarket notification submitted by Gas-Vak for the device "GAS-VAK(R), MODEL 300". The FDA issued a decision of Substantially Equivalent on August 7, 1989. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. Gas-Vak has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 1989
- Date Received
- January 31, 1989
- 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