ABSOCLEAR

Dressing, Wound, Drug

PHARMAPLAST S.A.E.

The following data is part of a premarket notification filed by Pharmaplast S.a.e. with the FDA for Absoclear.

Pre-market Notification Details

• Device ID: K130553
• 510k Number: K130553
• Device Name: ABSOCLEAR
• Classification: Dressing, Wound, Drug
• Applicant: PHARMAPLAST S.A.E. 1016 TOBIANO LANE Raleigh, NC 27614
• Contact: Cynthia Pritchard
• Correspondent: Cynthia Pritchard; PHARMAPLAST S.A.E. 1016 TOBIANO LANE Raleigh, NC 27614
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-03-04
• Decision Date: 2013-07-03
• Summary: summary