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 |