The following data is part of a premarket notification filed by Iob Medical Inc with the FDA for Iob Disposable Speculum.
| Device ID | K132668 |
| 510k Number | K132668 |
| Device Name: | IOB DISPOSABLE SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | IOB MEDICAL INC 504E DIAMOND AVE. SUITE F Gaithersburg, MD 20877 |
| Contact | Joe Xia |
| Correspondent | Joe Xia IOB MEDICAL INC 504E DIAMOND AVE. SUITE F Gaithersburg, MD 20877 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-27 |
| Decision Date | 2014-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06951013000416 | K132668 | 000 |
| 06951013000409 | K132668 | 000 |
| 06951013000393 | K132668 | 000 |