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RE: RE: [IP] pump comparison - follow up

After checking the FDA web site, I found the following letter of approval,
which reads, in part:

"We have reviewed your Section 510(k) notification of intent to market the
device referenced above and we have determined the device is substantially
equivalent (for the indications for the use stated in the enclosure) to
devices marketed in interstate commerce prior to May 28, 1976, the enactment
date of the Medical Device Amendments, or to devices that have been
reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act)."

You may read the full finding at http://www.fda.gov/cdrh/pdf/k993184.pdf.

Jim Handsfield
email @ redacted OR
email @ redacted

The opinions expressed are mine and may not represent those of my wife who
runs our house and makes more important decisions than I do.
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