The following data is part of a premarket notification filed by G. Dundas Co.,inc. with the FDA for Active Waste Gas Scavenger.
Device ID | K110930 |
510k Number | K110930 |
Device Name: | ACTIVE WASTE GAS SCAVENGER |
Classification | Apparatus, Gas-scavenging |
Applicant | G. DUNDAS CO.,INC. 24301 ROBERTS DR. Black Diamond, WA 98010 |
Contact | Michelle Norrie |
Correspondent | Michelle Norrie G. DUNDAS CO.,INC. 24301 ROBERTS DR. Black Diamond, WA 98010 |
Product Code | CBN |
CFR Regulation Number | 868.5430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-04 |
Decision Date | 2011-06-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00863735000307 | K110930 | 000 |