EPIVIEW

Dressing, Wound And Burn, Occlusive

CONVATEC, A BRISTOL-MYERS SQUIBB CO.

The following data is part of a premarket notification filed by Convatec, A Bristol-myers Squibb Co. with the FDA for Epiview.

Pre-market Notification Details

• Device ID: K940895
• 510k Number: K940895
• Device Name: EPIVIEW
• Classification: Dressing, Wound And Burn, Occlusive
• Applicant: CONVATEC, A BRISTOL-MYERS SQUIBB CO. 200 HEADQUARTERS PARK DR. Skillman, NJ 08558
• Contact: Karen Horgan
• Correspondent: Karen Horgan; CONVATEC, A BRISTOL-MYERS SQUIBB CO. 200 HEADQUARTERS PARK DR. Skillman, NJ 08558
• Product Code: MGP
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-02-24
• Decision Date: 1994-11-22