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 |
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