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510(k) K010986

Device
LUNAPADS
Applicant
LUNAPADS INTERNATIONAL PRODUCTS LTD
510(k) number
K010986
Product code
NUQ  
Decision
Substantially Equivalent (SESE)
Decision date
2001-06-13
Date received
2001-04-02
Regulation
884.5435
Classification name
Pad, Menstrual, Reusable
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
SUZANNE SIEMENS
Address
207 W. 6th Ave. Vancouver Bc CA V5Y 1K7 V5Y 1K7

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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