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510(k) K803177

MOIST HEAT PACK by Duro-Med Ind., Inc. — Product Code IMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1980
Date Received
December 16, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Heat, Moist
Device Class
Class I
Regulation Number
890.5730
Review Panel
PM
Submission Type

Other clearances by Duro-Med Ind., Inc.

  • K823903 — RUBBER INFLATABLE RING (January 14, 1983)

Other clearances for product code IMA

  • K150139 — Rachel's Remedy (May 22, 2015)
  • K950701 — WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER (March 24, 1995)
  • K841698 — HEAT PACK (May 10, 1984)
  • K832803 — STEAM PAK MOIST HEAT (September 20, 1983)
  • K823622 — INSULATED THERMOELASTOMER MITT (December 30, 1982)
  • K791653 — REUSABLE MOIST HEAT PACK (September 7, 1979)
  • K790904 — STAO-HOTPACK (May 18, 1979)