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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 NumberS005
Date Received02/07/2002
Decision Date08/06/2002
Product Code
MOA[ Registered Establishments with MOA ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the wavstat optical biopsy system (obs) to be extended to include the wavstat optical biopsy system model iii console.
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