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
K834128Substantially Equivalent

Globe Res-Q-Flo

Globe Safety Equipment, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834128 is the FDA 510(k) clearance record for GLOBE RES-Q-FLO, cleared for Globe Safety Equipment, Inc. on . FDA records list one 510(k) clearance for Globe Safety Equipment, Inc. As of , FDA records show no recalls naming K834128.

Clearance record

Decision date
Received
(30 days to decision)
Review panel
Unknown
Applicant
Globe Safety Equipment, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No