PlasmaFlow

Sleeve, Limb, Compressible

MANAMED, INC

The following data is part of a premarket notification filed by Manamed, Inc with the FDA for Plasmaflow.

Pre-market Notification Details

• Device ID: K160318
• 510k Number: K160318
• Device Name: PlasmaFlow
• Classification: Sleeve, Limb, Compressible
• Applicant: MANAMED, INC 287 CABRILLO ST. UNIT C Costa Mesa, CA 92627
• Contact: Trevor Theriot
• Correspondent: Dave Yungvirt; THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111
• Product Code: JOW
• CFR Regulation Number: 870.5800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2016-02-05
• Decision Date: 2016-04-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850033615005	K160318	000