The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Sutureless Anchor.
Device ID | K984490 |
510k Number | K984490 |
Device Name: | SUTURELESS ANCHOR |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough, MA 01752 |
Contact | Kathleen Morahan |
Correspondent | Kathleen Morahan INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough, MA 01752 |
Product Code | MAI |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-12-17 |
Decision Date | 1999-03-01 |
Summary: | summary |