DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414

Dressing, Wound, Drug

DYNAREX CORP.

The following data is part of a premarket notification filed by Dynarex Corp. with the FDA for Dynarex Iodoform Packing Strips, Models 3411, 3412, 3413, 3414.

Pre-market Notification Details

• Device ID: K012816
• 510k Number: K012816
• Device Name: DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
• Classification: Dressing, Wound, Drug
• Applicant: DYNAREX CORP. 7736 WOODSIDE COURT Maineville, OH 45039
• Contact: John Gagliardi
• Correspondent: John Gagliardi; DYNAREX CORP. 7736 WOODSIDE COURT Maineville, OH 45039
• 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: 2001-08-22
• Decision Date: 2002-10-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00616784340425	K012816	000
00616784340326	K012816	000
00616784340227	K012816	000
00616784340128	K012816	000