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
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K828661Substantially Equivalent

Barium Enemas

The Healthcare Group, Inc., West Valley UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K828661 is the FDA 510(k) clearance record for BARIUM ENEMAS, cleared for The Healthcare Group, Inc. on . FDA records list 2 510(k) clearances for The Healthcare Group, Inc., from to . As of , FDA records show no recalls naming K828661.

Clearance record

Decision date
Received
(63 days to decision)
Review panel
Unknown
Applicant
The Healthcare Group, Inc. 2601 S. Constitution Blvd., West Valley UT
Third party review
No