The following data is part of a premarket notification filed by Medicon, Inc. with the FDA for Vacuum Stretcher Immobilizer.
Device ID | K840034 |
510k Number | K840034 |
Device Name: | VACUUM STRETCHER IMMOBILIZER |
Classification | Stretcher, Hand-carried |
Applicant | MEDICON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPP |
CFR Regulation Number | 880.6900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-05 |
Decision Date | 1984-02-27 |