The following data is part of a premarket notification filed by Sparta Surgical Corp. with the FDA for Vesseloops.
Device ID | K905240 |
510k Number | K905240 |
Device Name: | VESSELOOPS |
Classification | Instrument, Surgical, Disposable |
Applicant | SPARTA SURGICAL CORP. 368 FAIRVIEW AVE. P.O. BOX 268 Hammonton, NJ 08037 |
Contact | Carleton F Kimber |
Correspondent | Carleton F Kimber SPARTA SURGICAL CORP. 368 FAIRVIEW AVE. P.O. BOX 268 Hammonton, NJ 08037 |
Product Code | KDC |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-20 |
Decision Date | 1991-02-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VESSELOOPS 74471299 not registered Dead/Abandoned |
MAXXIM MEDICAL CORPORATION 1993-12-20 |
VESSELOOPS 72423303 0973493 Live/Registered |
MED GENERAL, INC. 1972-05-04 |