510(k) K890438

GAS-VAK(R), MODEL 300 by Gas-Vak — Product Code CBN

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