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510(k) K884436

MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 by Harris Mfg. Co. — Product Code KSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1988
Date Received
October 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Refrigerator, Freezer, Blood Storage
Device Class
Class II
Regulation Number
864.9700
Review Panel
HE
Submission Type

Other clearances by Harris Mfg. Co.

  • K921906 — HARRIS MODEL 2000 (November 2, 1992)

Other clearances for product code KSE

  • K813327 — SEPCOR TEMPERATURE MONITOR (December 31, 1981)
  • K802319 — HEMOTEMP TM (October 10, 1980)
  • K800667 — MONITEMP BLOOD PACK TEMP. MONITOR (April 16, 1980)