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510(k) K942389

TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES by Hogan & Hartson — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1996
Date Received
May 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type

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  • K973162 — DUAL RADIATION TARGETING SYSTEM DRTS DRAPE (November 20, 1997)
  • K950169 — RIBOSOMAL P EIA TEST SYSTEM (May 23, 1996)
  • K946215 — CARDIOLIPIN G EIA TEST SYSTEM (January 24, 1996)
  • K946217 — CARDIOLIPIN M EIA TEST SYSTEM (January 24, 1996)
  • K946216 — CARDIOLIPIN A EIA TEST SYSTEM (January 24, 1996)
  • K946186 — CHAL-2500 (August 14, 1995)
  • K941566 — COMPUSPEAK (June 30, 1995)
  • K950110 — MARDX MITOCHONDRIA EIA TEST SYSTEM (May 15, 1995)

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