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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameWAVSTAT OPTICAL BIOPSY SYSTEM
Classification Nameanalyzer, diagnostic, fiber optic (colon)
Generic Nameanalyzer, diagnostic, fiber optic (colon)
ApplicantSPECTRASCIENCE, INC.
PMA NumberP990050
Supplement NumberS006
Date Received07/19/2005
Decision Date03/28/2006
Product Code
MOA[ Registered Establishments with MOA ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at spectrascience, inc. , san diego, california.
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