The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Titanium Hemoclips.
Device ID | K962016 |
510k Number | K962016 |
Device Name: | MEDLINE TITANIUM HEMOCLIPS |
Classification | Clip, Implantable |
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 | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-23 |
Decision Date | 1996-07-24 |