The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Lancer Ice Cube.
Device ID | K782077 |
510k Number | K782077 |
Device Name: | LANCER ICE CUBE |
Classification | Freezer |
Applicant | SHERWOOD MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JRM |
CFR Regulation Number | 862.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-13 |
Decision Date | 1979-04-03 |