The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Band Bags And Equipment Covers.
Device ID | K032065 |
510k Number | K032065 |
Device Name: | MEDLINE BAND BAGS AND EQUIPMENT COVERS |
Classification | Cover, Barrier, Protective |
Applicant | MEDLINE INDUSTRIES, INC. 1170 S. NORTHPOINT BLVD. Waukegan, IL 60085 |
Contact | Lara N Simmons |
Correspondent | Lara N Simmons MEDLINE INDUSTRIES, INC. 1170 S. NORTHPOINT BLVD. Waukegan, IL 60085 |
Product Code | MMP |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-03 |
Decision Date | 2003-09-22 |