The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Boies Nasal Fracture Elevator.
Device ID | K772391 |
510k Number | K772391 |
Device Name: | BOIES NASAL FRACTURE ELEVATOR |
Classification | Elevator, Ent |
Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KAD |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-27 |
Decision Date | 1978-01-17 |