The following data is part of a premarket notification filed by Medical Specialties Intl., Inc. with the FDA for Manifold.
Device ID | K972654 |
510k Number | K972654 |
Device Name: | MANIFOLD |
Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
Applicant | MEDICAL SPECIALTIES INTL., INC. 615 JASMINE AVENUE N. Tarpon Springs, FL 34689 |
Contact | Larry G Junker |
Correspondent | Larry G Junker MEDICAL SPECIALTIES INTL., INC. 615 JASMINE AVENUE N. Tarpon Springs, FL 34689 |
Product Code | DTL |
CFR Regulation Number | 870.4290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-15 |
Decision Date | 1997-10-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() MANIFOLD 97654961 not registered Live/Pending |
Rosen's, Inc. 2022-10-31 |
![]() MANIFOLD 97085914 not registered Live/Pending |
Adaptive Sensory Technology, Inc. 2021-10-21 |
![]() MANIFOLD 88125327 not registered Live/Pending |
Red.com, LLC 2018-09-20 |
![]() MANIFOLD 88000660 not registered Live/Pending |
Arigato Machine Inc. 2018-06-14 |
![]() MANIFOLD 88000620 not registered Live/Pending |
Arigato Machine Inc. 2018-06-14 |
![]() MANIFOLD 87872454 not registered Live/Pending |
Manifold Inc. 2018-04-11 |
![]() MANIFOLD 87857775 not registered Live/Pending |
Adaptive Sensory Technology, Inc. 2018-03-30 |
![]() MANIFOLD 86752154 5360421 Live/Registered |
SZ DJI Technology Co., Ltd. 2015-09-09 |
![]() MANIFOLD 86128314 4800387 Live/Registered |
Kai U.S.A., Ltd. 2013-11-25 |
![]() MANIFOLD 79129490 4423671 Live/Registered |
OKAMURA CORPORATION 2013-03-22 |
![]() MANIFOLD 78521723 3045772 Live/Registered |
MANIFOLD SOFTWARE LIMITED 2004-11-23 |
![]() MANIFOLD 78170905 not registered Dead/Abandoned |
Alexander, Todd A., 2002-10-04 |