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510(k) K173351

Panpac Flexi Shelf Pessary by Panpac Medical Corporation — Product Code HHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2018
Date Received
October 25, 2017
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pessary, Vaginal
Device Class
Class II
Regulation Number
884.3575
Review Panel
OB
Submission Type

Other clearances by Panpac Medical Corporation

  • 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)
  • K092984 — PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 (April 7, 2010)

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