The following data is part of a premarket notification filed by Horizon Surgical, Inc. with the FDA for Horizon Surgical Ligating And Marking Clip.
Device ID | K901303 |
510k Number | K901303 |
Device Name: | HORIZON SURGICAL LIGATING AND MARKING CLIP |
Classification | Clip, Vascular |
Applicant | HORIZON SURGICAL, INC. P.O. BOX 3460 Evergreen, CO 80439 |
Contact | Frank N Easterbrook |
Correspondent | Frank N Easterbrook HORIZON SURGICAL, INC. P.O. BOX 3460 Evergreen, CO 80439 |
Product Code | DSS |
CFR Regulation Number | 870.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-20 |
Decision Date | 1990-06-05 |