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510(k) K092980

PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 by Panpac Medical Corporation — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2010
Date Received
September 28, 2009
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)
  • K102898 — BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY (December 15, 2011)
  • K092982 — THE PANPAC SUCTION CURETTE (July 26, 2010)
  • K092981 — PANPAC VAGINAL PESSARY (July 22, 2010)
  • K092983 — PANPAC HSG CATHETER SET (June 7, 2010)

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