The following data is part of a premarket notification filed by Nimbic Systems, Llc with the FDA for Abs Blower, Abs Nozzle, Model 1001.
Device ID | K092801 |
510k Number | K092801 |
Device Name: | ABS BLOWER, ABS NOZZLE, MODEL 1001 |
Classification | Air Filter Portable Apparatus |
Applicant | NIMBIC SYSTEMS, LLC 4910 WRIGHT ROAD, SUITE 170 Stafford, TX 77477 |
Contact | Sean Self |
Correspondent | Sean Self NIMBIC SYSTEMS, LLC 4910 WRIGHT ROAD, SUITE 170 Stafford, TX 77477 |
Product Code | ORC |
CFR Regulation Number | 878.5070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-11 |
Decision Date | 2011-05-20 |
Summary: | summary |