The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Tube-strap.
Device ID | K791781 |
510k Number | K791781 |
Device Name: | TUBE-STRAP |
Classification | Support, Breathing Tube |
Applicant | OLYMPIC MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JAY |
CFR Regulation Number | 868.5280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-09-11 |
Decision Date | 1979-09-19 |