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510(k) K062438

BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 by Cook Ob/Gyn — Product Code KNA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2006
Date Received
August 21, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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  • K983591 — INTRATUBAL TRANSFER SETS (December 21, 1998)

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  • K082939 — COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 (September 3, 2009)
  • K060289 — EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 (July 7, 2006)
  • K013597 — TAMPONADE UTERINE BALLOON CATHETER SET (April 17, 2002)
  • K014248 — DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER (March 21, 2002)
  • K001590 — DND 101 (August 2, 2000)
  • K990738 — DR. JAHANGER'S CUTTER (October 29, 1999)
  • K990045 — BERACLAMP, MODEL BC-1 (May 24, 1999)