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510(k) K911262

DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER by Ethicon, Inc. — Product Code GEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1991
Date Received
March 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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  • K904881 — DISPOSABLE YANKAUER SUCTION TUBE (March 6, 1991)
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  • K904218 — SUCTION SYSTEM (October 31, 1990)
  • K901718 — KLEIN LAMPREY-CANNULA(TM) (May 24, 1990)
  • K901717 — KLEIN MICRO-CANNULA(TM) (May 24, 1990)