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 |