510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K844142Substantially Equivalent

Gore-Tex Tissue Matrix

W. L. Gore & Associates, Inc., Flagstaff AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844142 is the FDA 510(k) clearance record for GORE-TEX TISSUE MATRIX, cleared for W. L. Gore & Associates, Inc. on . FDA records list 169 510(k) clearances for W. L. Gore & Associates, Inc., from to . As of , FDA records show no recalls naming K844142.

Clearance record

Decision date
Received
(248 days to decision)
Review panel
Unknown
Applicant
W. L. Gore & Associates, Inc. 3450 W. Kiltie Ln., Flagstaff AZ
Third party review
No