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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K828661
Device Name BARIUM ENEMAS
Applicant
The Healthcare Group, Inc.
2601 S. Constitution Blvd.
West Valley,  UT  84119
Correspondent
The Healthcare Group, Inc.
2601 S. Constitution Blvd.
West Valley,  UT  84119
Date Received11/15/1982
Decision Date 01/17/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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