The following data is part of a premarket notification filed by Clearflow, Inc. with the FDA for Pleuraflow System.
Device ID | K153681 |
510k Number | K153681 |
Device Name: | PleuraFlow System |
Classification | Wound Drain Catheter System |
Applicant | CLEARFLOW, INC. S. SUNKIST ST, SUITE E Anaheim, CA 92806 |
Contact | Dov Gal |
Correspondent | Dov Gal CLEARFLOW, INC. 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 | 2015-12-22 |
Decision Date | 2016-01-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10856449006045 | K153681 | 000 |