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FDA 510(k) Application Details - K981821
Device Classification Name
Light, Surgical, Floor Standing
More FDA Info for this Device
510(K) Number
K981821
Device Name
Light, Surgical, Floor Standing
Applicant
ANGIOLAZ, INC.
INDUSTRIAL PARK
BELLOWS FALLS, VT 05101-0556 US
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Contact
JOHN D PLUMADORE
Other 510(k) Applications for this Contact
Regulation Number
878.4580
More FDA Info for this Regulation Number
Classification Product Code
FSS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/22/1998
Decision Date
07/29/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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