The following data is part of a premarket notification filed by Dukal Corp. with the FDA for Dukal Disposable Vaginal Speculum, Small, Medium, And Large.
| Device ID | K020726 |
| 510k Number | K020726 |
| Device Name: | DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | DUKAL CORP. 3234 ELLA LN. New Port Riche, FL 34655 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb DUKAL CORP. 3234 ELLA LN. New Port Riche, FL 34655 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-06 |
| Decision Date | 2002-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00665973015644 | K020726 | 000 |
| 00665973015637 | K020726 | 000 |
| 00665973015620 | K020726 | 000 |
| 20607415001833 | K020726 | 000 |
| 20607415001819 | K020726 | 000 |
| 20607415001796 | K020726 | 000 |