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510(k) K875275

WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER by Sterling Drug, Inc. — Product Code JTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1988
Date Received
December 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bath, Incubators/Water, All
Device Class
Class I
Regulation Number
866.2540
Review Panel
MI
Submission Type

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  • K820023 — CONAGRAF TM DURAPATITE CONES (February 24, 1982)
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  • K813257 — ALVEOGRAF DURAPATITE(18-40 MESH) (January 5, 1982)
  • K813070 — PERIOGRAF (November 20, 1981)
  • K780209 — DILUTION SPIKE (April 10, 1978)

Other clearances for product code JTQ

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  • K830322 — C.A.T. REAGENT KIT (March 28, 1983)
  • K830227 — AUTOMATED ELISA READER LBI 300 (March 10, 1983)
  • K830405 — LBI-100 37DEGREES INCUBATOR (March 10, 1983)
  • K822564 — WATER BATH (September 14, 1982)
  • K812826 — FORMA CH/P GAS PROCESSOR (October 23, 1981)
  • K812340 — TITERTEK MICROPLATE INCUBATOR (September 23, 1981)
  • K801462 — SPOR-O-THERM (July 28, 1980)
  • K792060 — TEMPTRONIC 100 WATER BATH (December 4, 1979)