The following data is part of a premarket notification filed by Hdc Corp. with the FDA for V-cath.
Device ID | K964966 |
510k Number | K964966 |
Device Name: | V-CATH |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
Contact | Gretchen Marchesani |
Correspondent | Gretchen Marchesani HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-11 |
Decision Date | 1997-03-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
V-CATH 76187003 2506689 Dead/Cancelled |
NEO MEDICAL INC. 2000-12-27 |
V-CATH 74014806 1656725 Dead/Cancelled |
HDC CORPORATION 1989-12-28 |