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510(k) K921928

SOFT-COVER by Adroit Medical Systems, Inc. — Product Code FMW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1992
Date Received
April 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Mattress (Medical Purposes)
Device Class
Class I
Regulation Number
880.6190
Review Panel
HO
Submission Type

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  • K970197 — HTP-1500 LOCALIZED HEAT THERAPY PUMP (September 10, 1997)
  • K962983 — STERILE SOFT-TEMP (January 10, 1997)
  • K921920 — SOFT-TEMP (December 11, 1992)

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