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510(k) K893135

GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER by Premium Plastics, Inc. — Product Code JOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1989
Date Received
April 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter And Tip, Suction
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

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  • K890107 — GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT (October 24, 1989)
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  • K800440 — STERILE SPONGE BOWLS (April 29, 1980)
  • K771448 — STERILE SUTURE REMOVAL KIT (September 6, 1977)

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