The following data is part of a premarket notification filed by Akcess Medical Products, Inc. with the FDA for Akcess-cath.
Device ID | K925818 |
510k Number | K925818 |
Device Name: | AKCESS-CATH |
Classification | Catheter, Subclavian |
Applicant | AKCESS MEDICAL PRODUCTS, INC. 201 NORTH CENTER DR. New Brunswick, NJ 08902 |
Contact | Balbir B Kapany |
Correspondent | Balbir B Kapany AKCESS MEDICAL PRODUCTS, INC. 201 NORTH CENTER DR. New Brunswick, NJ 08902 |
Product Code | LFJ |
CFR Regulation Number | 876.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-17 |
Decision Date | 1994-04-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AKCESS-CATH 74218917 1762018 Dead/Cancelled |
NEOSTAR MEDICAL TECHNOLOGIES, INC. 1991-11-04 |