The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore-tex Dualmesh Plus Biomaterial With Holes.
Device ID | K962401 |
510k Number | K962401 |
Device Name: | GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES |
Classification | Mesh, Surgical, Polymeric |
Applicant | W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LN. P.O. BOX 900 Flagstaff, AZ 86002 -0900 |
Contact | R. Larry Pratt |
Correspondent | R. Larry Pratt W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LN. P.O. BOX 900 Flagstaff, AZ 86002 -0900 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-21 |
Decision Date | 1996-09-03 |
Summary: | summary |