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510(k) K962881

KSEA CULDOCENTESIS SET by Karl Storz Endoscopy — Product Code HEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1996
Date Received
July 24, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culdoscope (And Accessories)
Device Class
Class II
Regulation Number
884.1640
Review Panel
OB
Submission Type

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  • K011700 — MODULITH SLK LITHOTRIPTER (August 16, 2002)
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  • K013107 — BIOABSORBABLE INTERFERENCE SCREW MEGAFIX (February 26, 2002)
  • K011841 — KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR (September 10, 2001)
  • K010569 — KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP (April 9, 2001)

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