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510(k) K913300

LAPAROSTAT(TM) by Cook Ob/Gyn — Product Code HAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1992
Date Received
July 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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  • K983593 — OVUM PICK-UP ASPIRATION NEEDLES (January 21, 1999)

Other clearances for product code HAM

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  • K993306 — NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4 (November 3, 1999)
  • K945861 — BERGEN 710 ESU (March 1, 1995)
  • K920100 — GSU HANDPIECE ADAPTER (February 3, 1992)
  • K911353 — EMC MODEL NO. STATOME 900 (June 24, 1991)
  • K901248 — ABC HANDPIECE ADAPTER (April 3, 1990)
  • K881334 — LIGHT COAGULATOR LC 250 (November 16, 1989)
  • K895337 — ELECTROSURGICAL COAGULATION SUCTION TUBE (September 15, 1989)
  • K894762 — B100 DISPOSABLE HANDPIECE (September 15, 1989)