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510(k) K102898

BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE by Panpac Medical Corporation — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2011
Date Received
September 30, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Manipulator/Injector, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Panpac Medical Corporation

  • K173351 — Panpac Flexi Shelf Pessary (October 31, 2018)
  • K161106 — PANPAC DISPOSABLE VACUUM CURETTES (January 13, 2017)
  • K153422 — Panpac Disposable Pessary Fitting Set (July 14, 2016)
  • K132670 — PANPAC INFLATABLE DOCUT PESSARY (June 4, 2014)
  • K130087 — PANPAC WORD/BARTHOLIN CATHETER (January 10, 2014)
  • K130273 — PANPAC VAGINAL DILATORS (August 8, 2013)
  • K092982 — THE PANPAC SUCTION CURETTE (July 26, 2010)
  • K092981 — PANPAC VAGINAL PESSARY (July 22, 2010)
  • K092983 — PANPAC HSG CATHETER SET (June 7, 2010)
  • K092984 — PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 (April 7, 2010)

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  • K222798 — Rejoni Intrauterine Catheter (December 16, 2022)
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  • K181770 — Intrauterine Access Balloon Catheter, Selective Salpingography Catheter (March 29, 2019)