The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Allport Mastoid Retractors.
Device ID | K772392 |
510k Number | K772392 |
Device Name: | ALLPORT MASTOID RETRACTORS |
Classification | Retractor, Ent |
Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KAL |
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 |