The following data is part of a premarket notification filed by Merck, Sharp & Dohme with the FDA for Lightcast Ii Carbide Blade.
Device ID | K760605 |
510k Number | K760605 |
Device Name: | LIGHTCAST II CARBIDE BLADE |
Classification | Blade, Scalpel |
Applicant | MERCK, SHARP & DOHME 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GES |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-08 |
Decision Date | 1976-10-05 |