The following data is part of a premarket notification filed by Influence, Inc. with the FDA for Influence Clip System.
Device ID | K981631 |
510k Number | K981631 |
Device Name: | INFLUENCE CLIP SYSTEM |
Classification | Clip, Implantable |
Applicant | INFLUENCE, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
Contact | Jonathan S Kahan |
Correspondent | Jonathan S Kahan INFLUENCE, INC. 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-05-07 |
Decision Date | 1998-07-28 |
Summary: | summary |