The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Nice Pack.
Device ID | K832193 |
510k Number | K832193 |
Device Name: | NICE PACK |
Classification | Pack, Hot Or Cold, Reusable |
Applicant | UNIVERSAL MEDICAL INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IME |
CFR Regulation Number | 890.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-08 |
Decision Date | 1983-08-31 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NICE PACK 86604632 not registered Dead/Abandoned |
ZOOMWORKS, LLC 2015-04-21 |