Barium Enemas

FDA 510(k) K828661 · The Healthcare Group, Inc.

Substantially Equivalent

510(k) numberK828661

Submission

Device name
Barium Enemas
Applicant
The Healthcare Group, Inc.
West Valley, UT, US
Received
November 15, 1982
Decision date
January 17, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

No product code recorded.

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Questions and answers

When was Barium Enemas cleared by the FDA?

Barium Enemas (K828661) received a 510(k) decision of Substantially Equivalent on January 17, 1983, 63 days after the submission was received.