The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Dexide Endo-lube Kit.
| Device ID | K953611 |
| 510k Number | K953611 |
| Device Name: | DEXIDE ENDO-LUBE KIT |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | DEXIDE, INC. 7509 FLAGSTONE DR. Fort Worth, TX 76118 |
| Contact | Roger Cooper |
| Correspondent | Roger Cooper 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 | 1995-08-02 |
| Decision Date | 1995-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521066564 | K953611 | 000 |