The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Monoject Scale Magnifier.
Device ID | K781459 |
510k Number | K781459 |
Device Name: | MONOJECT SCALE MAGNIFIER |
Classification | Reader, Bar, Ophthalmic |
Applicant | SHERWOOD MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HJY |
CFR Regulation Number | 886.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-08-23 |
Decision Date | 1978-10-24 |