The following data is part of a premarket notification filed by Akcess Medical Products, Inc. with the FDA for T Series Vessel Tips.
Device ID | K893438 |
510k Number | K893438 |
Device Name: | T SERIES VESSEL TIPS |
Classification | Tip, Vessel |
Applicant | AKCESS MEDICAL PRODUCTS, INC. 789 JERSEY AVE. New Brunswick, NJ 08901 |
Contact | Balbir Kapany |
Correspondent | Balbir Kapany AKCESS MEDICAL PRODUCTS, INC. 789 JERSEY AVE. New Brunswick, NJ 08901 |
Product Code | FKW |
CFR Regulation Number | 876.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-03 |
Decision Date | 1989-06-08 |