510(k) K091937 ยท HIB Speculum, Vaginal, Nonmetal
OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM
| Applicant | Obp Corporation, Lawerence MA, US |
| Decision | Substantially Equivalent, Sep 9, 2009 |
| Received | Jun 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091937
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2026 | OBP Medical Corporation OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small
REF: C020130-1 Open, Classified |
HIB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.