The following data is part of a premarket notification filed by G. Dundas Co.,inc. with the FDA for Passive Waste Gas Scavenger, Model 14600.
Device ID | K080039 |
510k Number | K080039 |
Device Name: | PASSIVE WASTE GAS SCAVENGER, MODEL 14600 |
Classification | Apparatus, Gas-scavenging |
Applicant | G. DUNDAS CO.,INC. 24301 ROBERTS DR. Black Diamond, WA 98010 |
Contact | Mario Sorci |
Correspondent | Mario Sorci G. DUNDAS CO.,INC. 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 | 2008-01-07 |
Decision Date | 2008-04-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00863735000314 | K080039 | 000 |