The following data is part of a premarket notification filed by Depalt Inc. with the FDA for Depalt Vaginal Specuim And Depalt Lighting System.
| Device ID | K072762 |
| 510k Number | K072762 |
| Device Name: | DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | DEPALT INC. 5013 STONEWICK COURT Plano, TX 75093 |
| Contact | Rajeev Patel |
| Correspondent | Rajeev Patel DEPALT INC. 5013 STONEWICK COURT Plano, TX 75093 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-28 |
| Decision Date | 2008-01-22 |
| Summary: | summary |