The following data is part of a premarket notification filed by G. Dundas Co. with the FDA for Model 1920 Waste Gas Scavenger.
Device ID | K963601 |
510k Number | K963601 |
Device Name: | MODEL 1920 WASTE GAS SCAVENGER |
Classification | Apparatus, Gas-scavenging |
Applicant | G. DUNDAS CO. 24301 ROBERTS DR. Black Diamond, WA 98010 |
Contact | Mario Sorci |
Correspondent | Mario Sorci G. DUNDAS CO. 24301 ROBERTS DR. Black Diamond, WA 98010 |
Product Code | CBN |
CFR Regulation Number | 868.5430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-09 |
Decision Date | 1997-04-28 |