The following data is part of a premarket notification filed by Applied Vascular Devices, Inc. with the FDA for Surgical Trocar And Cannula.
Device ID | K904379 |
510k Number | K904379 |
Device Name: | SURGICAL TROCAR AND CANNULA |
Classification | Laparoscope, Gynecologic (and Accessories) |
Applicant | APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
Contact | Jo Stegwell |
Correspondent | Jo Stegwell APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
Product Code | HET |
CFR Regulation Number | 884.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-25 |
Decision Date | 1990-12-21 |