Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft

Mesh, Surgical

COOK BIOTECH INCORPORATED

The following data is part of a premarket notification filed by Cook Biotech Incorporated with the FDA for Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft.

Pre-market Notification Details

• Device ID: K160869
• 510k Number: K160869
• Device Name: Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft
• Classification: Mesh, Surgical
• Applicant: COOK BIOTECH INCORPORATED 1425 INNOVATION PLACE West Lafayette, IN 47906
• Contact: Perry W. Guinn
• Correspondent: Nick Wang; COOK BIOTECH INCORPORATED 1425 INNOVATION PLACE West Lafayette, IN 47906
• Product Code: FTM
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-03-30
• Decision Date: 2016-04-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10827002138084	K160869	000
00810179630010	K160869	000
00810179630027	K160869	000
00810179630034	K160869	000
00827002125797	K160869	000
00827002125803	K160869	000
00827002125810	K160869	000
00827002128477	K160869	000
00827002131811	K160869	000
00827002132214	K160869	000
00827002135444	K160869	000
00827002313200	K160869	000
10827002128481	K160869	000
10827002131160	K160869	000
10827002138060	K160869	000
10827002138077	K160869	000
00810179630003	K160869	000