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510(k) K802016

Device
EYE APPLICATORS CAT.#980-983
Applicant
POLLAK (INTL.), LTD.
510(k) number
K802016
Product code
KXF  
Decision
Substantially Equivalent (SESE)
Decision date
1980-09-16
Date received
1980-08-20
Regulation
880.6025
Classification name
Applicator, Absorbent Tipped, Non-sterile
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KXF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K123184FINN CHAMBERS AQUASmartpractice2012-12-19
K103409ALLERGEAZE R CLEARSmartpractice2011-03-15
K063160ALLERGEAZE PATCH TEST CHAMBERSSmartpractice2006-12-22
K013820FINN CHAMBER (R)Epitest Ltd. OY2002-01-30
K992553IQ CHAMBERSDormer Laboratories, Inc.2000-04-12
K870762EAR APPLICATOR, CATALOG NO. 2229Treace Medical, Inc.1987-03-06
K843720COTTON TIPPED APPLICATORS, SINGLEAbco Dealers, Inc.1984-10-04
K820962COTTON SWABSDafoe & Dafoe, Inc.1982-04-20
K813506FARRORS TMJ CASSETTE HOLDERBrell Mar Products, Inc.1982-01-29
K811365HILL TOP CHAMBERHill Top Research, Inc.1981-08-20
K802580SUBCLAVIAN CATHETER INSERTION TRAYAmerican Pharmaseal Div. Ahsc1980-11-12
K802020PREP SET CAT.#908Pollak (Intl.), Ltd.1980-09-09
K791168DEXIDE DISPOSABLE PREP STICKDexide, Inc.1979-07-30
K791169DEXIDE DISPOSABLE SWAB STICKDexide, Inc.1979-07-30
K780929COTTON TIPPED POINTYoung Dental Manufacturing Co. 1, LLC1978-06-30

Legacy Summary#

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FDA Review#

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