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510(k) K800459

BARIUM SULFATE, USP IN SUSPENSION by Central Pharmaceuticals, Inc. — Product Code KTA

K800459 is an FDA 510(k) premarket notification submitted by Central Pharmaceuticals, Inc. for the device "BARIUM SULFATE, USP IN SUSPENSION". The FDA issued a decision of Substantially Equivalent on May 30, 1980. The device falls under product code KTA (Medium, Contrast, Radiologic), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1980
Date Received
February 29, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Medium, Contrast, Radiologic
Device Class
Class U
Regulation Number
Review Panel
RA
Submission Type

Other clearances for product code KTA

  • K800843 — MEDEFIZZ A & MEDEFIZZ B (June 17, 1980)
  • K800840 — MEDEFOAM-2 (June 17, 1980)
  • K800841 — MEDEBAR M (May 30, 1980)
  • K800839 — MEDESCAN (May 30, 1980)
  • K800844 — MEDEBAR XL (May 30, 1980)
  • K800842 — MEDEBAR XAC-90 (May 30, 1980)
  • K760736 — BARIMEX, BARIUM SULFATE COMPOUND (November 9, 1976)

FDA data resources