The following data is part of a premarket notification filed by Microsurge, Inc. with the FDA for Microsurge Veress Needle.
Device ID | K954520 |
510k Number | K954520 |
Device Name: | MICROSURGE VERESS NEEDLE |
Classification | Laparoscope, Gynecologic (and Accessories) |
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 | HET |
CFR Regulation Number | 884.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-28 |
Decision Date | 1995-10-16 |