The following data is part of a premarket notification filed by Obp Corporation with the FDA for Office-spec Disposable Side-opening Speculum.
| Device ID | K091937 |
| 510k Number | K091937 |
| Device Name: | OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | OBP CORPORATION 360 MERRIMACK STREET BUILDING 9 Lawrence, MA 01843 |
| Contact | Keith Isaacson |
| Correspondent | Keith Isaacson OBP CORPORATION 360 MERRIMACK STREET BUILDING 9 Lawrence, MA 01843 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-30 |
| Decision Date | 2009-09-09 |