The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Collagen Wound Dressing.
Device ID | K060456 |
510k Number | K060456 |
Device Name: | MEDLINE COLLAGEN WOUND DRESSING |
Classification | Dressing, Wound, Collagen |
Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
Contact | Lara N Simmons |
Correspondent | Lara N Simmons MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
Product Code | KGN |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-22 |
Decision Date | 2006-06-19 |