PMA P990050S006

Device
WAVSTAT OPTICAL BIOPSY SYSTEM
Applicant
Spectra Science
PMA number
P990050
Supplement
S006
Product code
MOA
Decision date
2006-03-28
Classification
Analyzer, Diagnostic, Fiber Optic (colon)
Generic name
ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT SPECTRASCIENCE, INC., SAN DIEGO, CALIFORNIA.

Current openFDA PMA Record#

Device
WAVSTAT OPTICAL BIOPSY SYSTEM
Applicant
Spectra Science
PMA number
P990050
Supplement
S006
Product code
MOA
Generic name
ANALYZER, DIAGNOSTIC, FIBER OPTIC (COLON)
Decision date
2006-03-28
Decision code
APPR
Date received
2005-07-19
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT SPECTRASCIENCE, INC., SAN DIEGO, CALIFORNIA.