The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Modification To Multaport Cannula, Reducer And Accessories.
Device ID | K990379 |
510k Number | K990379 |
Device Name: | MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | DEXIDE, INC. 7509 FLAGSTONE DR. Fort Worth, TX 76118 |
Contact | John Corzine |
Correspondent | John Corzine DEXIDE, INC. 7509 FLAGSTONE DR. Fort Worth, TX 76118 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-02-08 |
Decision Date | 1999-03-04 |
Summary: | summary |