The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Multaport Cannula Reducer And Accessories.
Device ID | K981941 |
510k Number | K981941 |
Device Name: | MULTAPORT CANNULA REDUCER AND ACCESSORIES |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | DEXIDE, INC. 7509 FLAGSTONE DR. Fort Worth, TX 76118 |
Contact | Lynette Caldwell |
Correspondent | Lynette Caldwell DEXIDE, INC. 7509 FLAGSTONE DR. Fort Worth, TX 76118 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-02 |
Decision Date | 1998-07-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20884521080840 | K981941 | 000 |
20884521080864 | K981941 | 000 |
20884521545134 | K981941 | 000 |
20884521080833 | K981941 | 000 |
20884521080826 | K981941 | 000 |