The following data is part of a premarket notification filed by Stat Path with the FDA for Microscope Slides Precoated W/histogrip & Poly-ly.
Device ID | K882357 |
510k Number | K882357 |
Device Name: | MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY |
Classification | Slides, Microscope |
Applicant | STAT PATH P.O. BOX 6 Riderwood, MD 21139 -0006 |
Contact | R Bostwick |
Correspondent | R Bostwick STAT PATH P.O. BOX 6 Riderwood, MD 21139 -0006 |
Product Code | KEW |
CFR Regulation Number | 864.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-07 |
Decision Date | 1988-06-16 |