The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Leigh Measuring Scale #7725.
Device ID | K801466 |
510k Number | K801466 |
Device Name: | LEIGH MEASURING SCALE #7725 |
Classification | Gauge, Lens, Ophthalmic |
Applicant | EDWARD WECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HLN |
CFR Regulation Number | 886.1420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-06-24 |
Decision Date | 1980-07-28 |