510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840498Substantially Equivalent

Exu-Dry Burn-Trauma Dressing-Various

Fraass Survival Systems, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840498 is the FDA 510(k) clearance record for EXU-DRY BURN-TRAUMA DRESSING-VARIOUS, cleared for Fraass Survival Systems, Inc. on . FDA records list 23 510(k) clearances for Fraass Survival Systems, Inc., from to . As of , FDA records show no recalls naming K840498.

Clearance record

Decision date
Received
(114 days to decision)
Review panel
Unknown
Applicant
Fraass Survival Systems, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No