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510(k) K933628

CYTOLOGY BRUSH by Bioteque America, Inc. — Product Code HHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1994
Date Received
July 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spatula, Cervical, Cytological
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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  • K013289 — BIOTEQUE VAGINAL PESSARIES (December 27, 2001)
  • K003380 — BIOTEQUE VAGINAL DILATOR (January 29, 2001)
  • K920633 — PESSARY FLEXIBLE SILICONE NICHOLS (November 8, 1995)
  • K920747 — PESSARY FLEXIBLE SILICONE DONUT RING (August 29, 1994)
  • K933521 — SPECULUM (March 7, 1994)
  • K920187 — FLEXIBLE SILICONE GELIHORN (October 23, 1992)
  • K920177 — VERSA-VIAL (July 13, 1992)

Other clearances for product code HHT

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  • K153128 — Kolplast Cervical Sample Collection Kit (January 13, 2017)
  • K141057 — DISPOSABLE CERVICAL BRUSH (May 14, 2015)
  • K111681 — HISTOBRUSH (January 19, 2012)
  • K083012 — PAPCONE (April 9, 2009)
  • K081522 — BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY (December 5, 2008)
  • K072381 — SOFTPAP CERVICAL CELL COLLECTOR (January 30, 2008)
  • K062433 — DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM (March 16, 2007)
  • K043369 — CERVEX-BRUSH COMBI (February 2, 2005)
  • K042527 — SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 (November 8, 2004)