The following data is part of a premarket notification filed by Staodynamics, Inc. with the FDA for Stao-hotpack.
Device ID | K790904 |
510k Number | K790904 |
Device Name: | STAO-HOTPACK |
Classification | Pack, Heat, Moist |
Applicant | STAODYNAMICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IMA |
CFR Regulation Number | 890.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-11 |
Decision Date | 1979-05-18 |