The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Ice Container I.c.e..
Device ID | K792182 |
510k Number | K792182 |
Device Name: | ICE CONTAINER I.C.E. |
Classification | Pack, Hot Or Cold, Reusable |
Applicant | DELTA MEDICAL INDUSTRIES 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 | 1979-10-29 |
Decision Date | 1979-11-15 |