The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Dexide Laparoscopic Accessories.
Device ID | K923845 |
510k Number | K923845 |
Device Name: | DEXIDE LAPAROSCOPIC ACCESSORIES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | DEXIDE, INC. 7509 FLAGSTONE DR. Fort Worth, TX 76118 |
Contact | Keith Jung |
Correspondent | Keith Jung DEXIDE, INC. 7509 FLAGSTONE DR. Fort Worth, TX 76118 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-31 |
Decision Date | 1992-11-25 |