The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Dexide Laparoscopic Kits.
Device ID | K924117 |
510k Number | K924117 |
Device Name: | DEXIDE LAPAROSCOPIC KITS |
Classification | Kit, Surgical Instrument, Disposable |
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 | KDD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-14 |
Decision Date | 1993-03-23 |