The following data is part of a premarket notification filed by Microsurge, Inc. with the FDA for Microsurge Laparoscopic Permaclip Cartridge With Implantable Clip.
Device ID | K964109 |
510k Number | K964109 |
Device Name: | MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLE CLIP |
Classification | Clip, Implantable |
Applicant | MICROSURGE, INC. 150 A ST. Needham, MA 02194 |
Contact | Richard Lariviere |
Correspondent | Richard Lariviere MICROSURGE, INC. 150 A ST. Needham, MA 02194 |
Product Code | FZP |
CFR Regulation Number | 878.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-10-15 |
Decision Date | 1996-11-27 |
Summary: | summary |