The following data is part of a premarket notification filed by Devmed Corp. with the FDA for Devmed Lap Wash Reusable Endoscopic Lens Wash Sheath.
| Device ID | K933416 |
| 510k Number | K933416 |
| Device Name: | DEVMED LAP WASH REUSABLE ENDOSCOPIC LENS WASH SHEATH |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | DEVMED CORP. P.O. BOX 30716 Palm Beach Gardens, FL 33420 |
| Contact | Gregory Wilita |
| Correspondent | Gregory Wilita DEVMED CORP. P.O. BOX 30716 Palm Beach Gardens, FL 33420 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-12 |
| Decision Date | 1993-08-10 |