The following data is part of a premarket notification filed by Clearflow, Inc. with the FDA for The Zip Accessory Shuttle For Pleuraflow System.
Device ID | K191733 |
510k Number | K191733 |
Device Name: | The ZIP Accessory Shuttle For PleuraFlow System |
Classification | Wound Drain Catheter System |
Applicant | ClearFlow, Inc. 1630 S. Sunkist St. Suite E Anaheim, CA 92806 |
Contact | Dov Gal |
Correspondent | Dov Gal ClearFlow, Inc. 1630 S. Sunkist St. Suite E Anaheim, CA 92806 |
Product Code | OTK |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-06-28 |
Decision Date | 2019-07-26 |
Summary: | summary |