The following data is part of a premarket notification filed by Lab Industries, Inc. with the FDA for Adt Disposable Scalpel W/stainless Steel.
Device ID | K830745 |
510k Number | K830745 |
Device Name: | ADT DISPOSABLE SCALPEL W/STAINLESS STEEL |
Classification | Scalpel, One-piece |
Applicant | LAB INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GDX |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-08 |
Decision Date | 1983-04-12 |