510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K822914Substantially Equivalent

1424 Tumistore

Life-Tech Intl., Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822914 is the FDA 510(k) clearance record for 1424 TUMISTORE, cleared for Life-Tech Intl., Inc. on . FDA records list 68 510(k) clearances for Life-Tech Intl., Inc., from to . As of , FDA records show no recalls naming K822914.

Clearance record

Decision date
Received
(63 days to decision)
Review panel
Unknown
Applicant
Life-Tech Intl., Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No