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510(k) K770456

PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT by Icn Pharmaceuticals, Inc. — Product Code CEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1977
Date Received
March 8, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Device Class
Class I
Regulation Number
862.1580
Review Panel
CH
Submission Type

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  • K914082 — SUAN FLAT DISSECTOR SPONGES (November 27, 1991)
  • K914086 — ICAN CYLINDRICAL SPONGES (October 9, 1991)
  • K914083 — ICAN K DISSECTOR SPONGES (October 9, 1991)
  • K914081 — ICAN COTTON RAYON BALLS (October 9, 1991)
  • K913446 — ICAN NEEDLE COUNTERS (September 13, 1991)
  • K904398 — WATER COLUMN RELIEF VALVE (July 9, 1991)
  • K770458 — BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. (May 10, 1977)

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