The following data is part of a premarket notification filed by Medical Repackers Co. with the FDA for Aik-100 Anesthesia Induction Kit/tray.
Device ID | K874674 |
510k Number | K874674 |
Device Name: | AIK-100 ANESTHESIA INDUCTION KIT/TRAY |
Classification | Anesthesia Conduction Kit |
Applicant | MEDICAL REPACKERS CO. P.O. BOX 1500 Fort Payne, AL 35967 |
Contact | Billy A Hodges |
Correspondent | Billy A Hodges MEDICAL REPACKERS CO. P.O. BOX 1500 Fort Payne, AL 35967 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-13 |
Decision Date | 1988-03-02 |