The following data is part of a premarket notification filed by Assist Fill, Llc with the FDA for Ez-assist-fill.
Device ID | K121661 |
510k Number | K121661 |
Device Name: | EZ-ASSIST-FILL |
Classification | Portable Liquid Oxygen Unit Stand |
Applicant | ASSIST FILL, LLC 55 NORTHERN BLVD STE 200 Great Neck, NY 11021 |
Contact | Griffin |
Correspondent | Griffin ASSIST FILL, LLC 55 NORTHERN BLVD STE 200 Great Neck, NY 11021 |
Product Code | PCM |
CFR Regulation Number | 890.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-06-05 |
Decision Date | 2012-12-27 |
Summary: | summary |