The following data is part of a premarket notification filed by Kelleher Corp. with the FDA for Bone Rongeuns Ent & Related Items.
Device ID | K822007 |
510k Number | K822007 |
Device Name: | BONE RONGEUNS ENT & RELATED ITEMS |
Classification | Rongeur, Mastoid |
Applicant | KELLEHER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JZA |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-08 |
Decision Date | 1982-08-12 |