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510(k) K864323

CYTOLOGY BRUSHES by Medical Packaging Corp. — Product Code HHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1987
Date Received
November 3, 1986
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

Other clearances by Medical Packaging Corp.

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  • K970597 — CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY- (March 24, 1997)
  • K964637 — CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA (December 24, 1996)
  • K936078 — CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED (August 16, 1994)
  • K932337 — CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM (August 16, 1994)
  • K915454 — CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT (April 8, 1992)
  • K881105 — CULTURE COLLECTION DEVICE (April 25, 1988)
  • K870398 — PAP-PAK CYTOBRUSH KIT (February 25, 1987)

Other clearances for product code HHT

  • K182049 — exCellerator Cervical Collection Device (April 25, 2019)
  • 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)