The following data is part of a premarket notification filed by Creative Laboratory Products, Inc. with the FDA for Clp Elevated Lipid Control.
Device ID | K895858 |
510k Number | K895858 |
Device Name: | CLP ELEVATED LIPID CONTROL |
Classification | Latex Patient Examination Glove |
Applicant | CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis, IN 46268 |
Contact | Gary Proksch |
Correspondent | Gary Proksch CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis, IN 46268 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-03 |
Decision Date | 1990-01-26 |