The following data is part of a premarket notification filed by Arleton Technical Products, Inc. with the FDA for Mirror Warmer.
Device ID | K781750 |
510k Number | K781750 |
Device Name: | MIRROR WARMER |
Classification | Mirror, Ent |
Applicant | ARLETON TECHNICAL PRODUCTS, 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 | 1978-10-16 |
Decision Date | 1979-01-17 |