The following data is part of a premarket notification filed by Medovations, Inc. with the FDA for Bulldog Biopsy Valve, Olympus And Fujinon;pentax Compatible;disposable Rrigating Adaptor, Sterile And Non-sterile.
| Device ID | K142068 |
| 510k Number | K142068 |
| Device Name: | BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | MEDOVATIONS, INC. 102 EAST KEEFE AVE. Milwaukee, WI 53212 |
| Contact | Laura Boll |
| Correspondent | Laura Boll MEDOVATIONS, INC. 102 EAST KEEFE AVE. Milwaukee, WI 53212 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-30 |
| Decision Date | 2015-03-10 |
| Summary: | summary |