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510(k) K950780

AMSINO CERVICAL SCRAPER by Amsino Intl., Inc. — Product Code HHT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1995
Date Received
February 21, 1995
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 Amsino Intl., Inc.

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  • K992719 — AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE (January 12, 2000)
  • K974042 — AMSURE CLEANSING ENEMA SET (December 19, 1997)
  • K973107 — AMSINO I.V. ADMINISTRATION SET (October 2, 1997)
  • K973199 — AMSINO SUCTION CATHETER (September 10, 1997)
  • K971929 — AMSINO URINARY LEG BAG (August 6, 1997)
  • K964745 — AMSINO URINARY DRAINAGE BAG (March 18, 1997)
  • K951528 — AMSINO DISPOSABLE VIGINAL SPECULUM (May 11, 1995)

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)