HYCURE

Dressing, Wound, Collagen

THE HYMED GROUP CORP.

The following data is part of a premarket notification filed by The Hymed Group Corp. with the FDA for Hycure.

Pre-market Notification Details

• Device ID: K955506
• 510k Number: K955506
• Device Name: HYCURE
• Classification: Dressing, Wound, Collagen
• Applicant: THE HYMED GROUP CORP. 1890 BUCKNELL DR. Bethlehem, PA 18015
• Contact: George D Petito
• Correspondent: George D Petito; THE HYMED GROUP CORP. 1890 BUCKNELL DR. Bethlehem, PA 18015
• Product Code: KGN
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-12-01
• Decision Date: 1996-01-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850019972085	K955506	000
00850019972078	K955506	000
00850019972092	K955506	000