ECOCEL

Bandage, Liquid

POLICHEM S.A.

The following data is part of a premarket notification filed by Polichem S.a. with the FDA for Ecocel.

Pre-market Notification Details

• Device ID: K083087
• 510k Number: K083087
• Device Name: ECOCEL
• Classification: Bandage, Liquid
• Applicant: POLICHEM S.A. 7361 CALHOUN PLACE SUITE 500 Rockville, MD 20855
• Contact: Hari Nagaradona
• Correspondent: Hari Nagaradona; POLICHEM S.A. 7361 CALHOUN PLACE SUITE 500 Rockville, MD 20855
• Product Code: KMF
• CFR Regulation Number: 880.5090 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-10-16
• Decision Date: 2009-08-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00343538510123	K083087	000