510(k) K101689 ยท KKX Drape, Surgical, Antimicrobial
EMM EQUIPMENT COVER-POLYTHYLENE
| Applicant | Exact Medical Manufacturing, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Sep 20, 2010 |
| Received | Jun 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101689
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2021 | Exact Medical Manufacturing, Inc. Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover
Bulk Non-sterile
Item ID: A-AU-0776NA Terminated |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.