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510(k) K895039

STERILE SALINE - FOR SUCTION CATHETER LUBRICATION by Aplicare, Inc. — Product Code GCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1989
Date Received
August 9, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

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  • K861557 — APLICARE SKIN PROTECTANT PREP PAD (July 11, 1986)
  • K861558 — APLICARE SKIN PROTECTANT SWABSTICK (June 4, 1986)
  • K833185 — ACETONE ALCOHOL PREP PAD (October 31, 1983)
  • K833183 — APLICARE ONE ACETONE ALCOHOL SWABSTICK (October 31, 1983)
  • K833184 — APLICARE THREE ALCOHOL SWABSTICKS (October 27, 1983)
  • K833182 — APLICARE ALCOHOL PREP PAD (October 27, 1983)

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