The following data is part of a premarket notification filed by Dynarex Corp. with the FDA for Dynarex Vaginal Specula 4900, Models 4911-small, 4912-medium, 4913-large.
| Device ID | K052314 |
| 510k Number | K052314 |
| Device Name: | DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | DYNAREX CORP. 10 GLENSHAW ST. Orangeburg, NY 10962 |
| Contact | James Hurlman |
| Correspondent | James Hurlman DYNAREX CORP. 10 GLENSHAW ST. Orangeburg, NY 10962 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-25 |
| Decision Date | 2005-11-09 |
| Summary: | summary |