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
00850017274082	K955506	000
00850017274075	K955506	000
00860000939508	K955506	000
00850017274099	K955506	000
00850017274105	K955506	000