The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Mirror, Laryngeal.
Device ID | K770053 |
510k Number | K770053 |
Device Name: | MIRROR, LARYNGEAL |
Classification | Mirror, Ent |
Applicant | WELCH ALLYN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KAI |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-01-10 |
Decision Date | 1977-01-18 |