The following data is part of a premarket notification filed by Mem Medical, Inc. with the FDA for Corrugated Tube With Mouthpiece.
Device ID | K790931 |
510k Number | K790931 |
Device Name: | CORRUGATED TUBE WITH MOUTHPIECE |
Classification | Mouthpiece, Breathing |
Applicant | MEM MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BYP |
CFR Regulation Number | 868.5620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-15 |
Decision Date | 1979-05-21 |