The following data is part of a premarket notification filed by Medical Repackers Co. with the FDA for Yankauer Suction Instru./laytex Gloves/suct. Cath..
Device ID | K881429 |
510k Number | K881429 |
Device Name: | YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH. |
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 | 1988-03-29 |
Decision Date | 1988-04-25 |