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510(k) K965040

INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL by Johnson & Johnson Medical, Inc. — Product Code HHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1997
Date Received
December 17, 1996
Clearance Type
Traditional
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 Johnson & Johnson Medical, Inc.

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  • K014129 — PROMOGRAN MATRIX WOUND DRESSING (February 14, 2002)
  • K001690 — PROTECTIV SAFETY BLOOD COLLECTION NEEDLE (July 31, 2000)
  • K982641 — ADVANCED NIBP MODULE (March 29, 1999)
  • K983362 — NU-GEL * WOUND DRESSING (December 16, 1998)
  • K982597 — FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE (August 20, 1998)
  • K974080 — CRITIKON SOFT BLOOD PRESSURE CUFF (May 18, 1998)
  • K980493 — I.V. CATHETER SYSTEM (April 28, 1998)
  • K972498 — OBSERVER * CENTRAL STATION (February 17, 1998)

Other clearances for product code HHW

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  • K240798 — Cntrl+ Bladder Support Pessary (December 17, 2024)
  • K232677 — Reia pessary (May 21, 2024)
  • K232525 — Yoni.Fit Bladder Support (May 17, 2024)
  • K233548 — Uresta® (April 3, 2024)
  • K231786 — Gynethotics™ Pessary (March 6, 2024)
  • K190277 — ProVate Vaginal Support (July 8, 2019)
  • K183468 — Revive Reusable Bladder Support (January 25, 2019)
  • K173351 — Panpac Flexi Shelf Pessary (October 31, 2018)