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510(k) K973981

SAFEPASS STERILIZATION POUCH by Adroit Medical Systems, Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1998
Date Received
October 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Adroit Medical Systems, Inc.

  • K073712 — SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 (June 6, 2008)
  • K970197 — HTP-1500 LOCALIZED HEAT THERAPY PUMP (September 10, 1997)
  • K962983 — STERILE SOFT-TEMP (January 10, 1997)
  • K921920 — SOFT-TEMP (December 11, 1992)
  • K921928 — SOFT-COVER (November 6, 1992)

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