The following data is part of a premarket notification filed by Applied Medical Technologies with the FDA for Vessel Occluder.
Device ID | K895726 |
510k Number | K895726 |
Device Name: | VESSEL OCCLUDER |
Classification | Clamp, Surgical, General & Plastic Surgery |
Applicant | APPLIED MEDICAL TECHNOLOGIES 6100 WEST CREEK RD. SUITE 25 Independence, OH 44131 |
Contact | Dean Secrest |
Correspondent | Dean Secrest APPLIED MEDICAL TECHNOLOGIES 6100 WEST CREEK RD. SUITE 25 Independence, OH 44131 |
Product Code | GDJ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-25 |
Decision Date | 1989-10-24 |