The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Myle's Guillotine.
Device ID | K822274 |
510k Number | K822274 |
Device Name: | MYLE'S GUILLOTINE |
Classification | Guillotine, Tonsil |
Applicant | KELLEHER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KBO |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-29 |
Decision Date | 1982-08-30 |