ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101

Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

ACRYMED, INC.

The following data is part of a premarket notification filed by Acrymed, Inc. with the FDA for Acryderm Silver Anttimicrobial Wound Gel Model# A-002101.

Pre-market Notification Details

• Device ID: K011994
• 510k Number: K011994
• Device Name: ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101
• Classification: Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
• Applicant: ACRYMED, INC. 12232 S.W. GARDEN PL. Portland, OR 97223
• Contact: Bruce Gibbins
• Correspondent: Bruce Gibbins; ACRYMED, INC. 12232 S.W. GARDEN PL. Portland, OR 97223
• Product Code: MGQ
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2001-06-26
• Decision Date: 2001-11-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
40080196296607	K011994	000
40080196296584	K011994	000
40080196296577	K011994	000
40080196296546	K011994	000
20193489002925	K011994	000