COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING

Dressing, Wound, Drug

COVALON TECHNOLOGIES LTD.

The following data is part of a premarket notification filed by Covalon Technologies Ltd. with the FDA for Collagran-collagen Wound Dressing, Collagranag-collagen W/silver Antimicrobial Wound Dressing.

Pre-market Notification Details

• Device ID: K060804
• 510k Number: K060804
• Device Name: COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING
• Classification: Dressing, Wound, Drug
• Applicant: COVALON TECHNOLOGIES LTD. 2033 IVERSON LANES Waxhaw, NC 28173
• Contact: Jacques Lemmetti
• Correspondent: Jacques Lemmetti; COVALON TECHNOLOGIES LTD. 2033 IVERSON LANES Waxhaw, NC 28173
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2006-03-24
• Decision Date: 2006-04-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00714196503442	K060804	000
04052199578767	K060804	000
04052199578736	K060804	000
00714196391445	K060804	000
00714196391421	K060804	000
00714196391322	K060804	000
00714196391308	K060804	000
00825439017272	K060804	000
00825439017258	K060804	000
00825439011348	K060804	000
00825439011317	K060804	000
00825439011287	K060804	000
00825439011256	K060804	000
00825439011225	K060804	000
00825439011195	K060804	000
00324357090447	K060804	000
40612479217230	K060804	000
40612479217254	K060804	000
00714196502223	K060804	000
00714196303448	K060804	000
00714196302229	K060804	000
00714196933522	K060804	000
00714196933515	K060804	000
00714196933126	K060804	000
00714196933119	K060804	000
00612479258365	K060804	000
00612479258334	K060804	000
00825439010365	K060804	000
00825439010198	K060804	000
00825439010105	K060804	000
00825439010075	K060804	000
00825439010044	K060804	000
00825439010013	K060804	000
00324357090225	K060804	000