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510(k) K991799

DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO by Davol Inc., Sub. C. R. Bard, Inc. — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1999
Date Received
May 26, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Hysteroscopic
Device Class
Class II
Regulation Number
884.1700
Review Panel
OB
Submission Type

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  • K081010 — BARD 3DMAX MESH (October 7, 2008)
  • K061754 — BARD COMPOSITE L/P MESH (October 23, 2006)
  • K061314 — BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH (June 2, 2006)
  • K051848 — SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, (August 11, 2005)
  • K050610 — SALUTE FIXATION SYSTEM (May 25, 2005)
  • K011069 — AQUASENS FLUID MONITORING SYSTEM (August 16, 2001)
  • K003674 — NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORB (December 8, 2000)
  • K991637 — BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 (June 22, 1999)

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