At 09:32 PM 9/17/00 -0400, Claudia wrote:
>That is why I feel they should not
>allow breastpumps at all on ebay.  I wrote Medela and asked for the place
>that they found that the FDA considers a breastpump a single user item.  When
>they write back, I plan on letting ebay know this too.  Maybe if we all
>looked up the pumps for a week or so and went to the community watch site and
>ALL let them know which pumps are used they will get sooooo tired of
>confirming our mail that they will just take the pumps off!!  Claudia

IMHO, only those breastpumps classified as single use pumps should be
eliminated from ebay.

The Pump in Style and the Purely Yours are governed by Title 21 of the Code
of Federal Regulations,
parts 800 - 895.
They also must assume compliance with the Current Good Manufacturing
Practice requirement as set forth in
the Quality System Regulation for Medical Devices: General Regulation 21
CFR part 820.

All this information may be found on the internet. I specifically found
this letter from the FDA to Hollister concerning the
marketing of their pump.  Here's the
url:  http://www.fda.gov/cdrh/pdf/k973501.pdf

For the Code of Federal Regulations, look up Section 21, parts 800-895.
This can be found at:
http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi

I am overwhelmed by the amount of information available.
For any of you who are affected with insominia, searching through this
stuff is a perfect cure.

Warmly,
Wendy Goldenthal
Nursing Mother Supplies, Devon, PA

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