The following data is part of a premarket notification filed by Stan-pak Ent. with the FDA for Frosted Glass Slides.
Device ID | K820100 |
510k Number | K820100 |
Device Name: | FROSTED GLASS SLIDES |
Classification | Slides, Microscope |
Applicant | STAN-PAK ENT. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KEW |
CFR Regulation Number | 864.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-13 |
Decision Date | 1982-03-04 |