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FDA 510(k) Application Details - K982042
Device Classification Name
More FDA Info for this Device
510(K) Number
K982042
Device Name
ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002
Applicant
ISLAND BIOSURGICAL, INC.
18 MEADOW LN.
MEREER ISLAND, WA 98040-5340 US
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Contact
HUNTER A MCKAY
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Regulation Number
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Classification Product Code
OTN
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Date Received
06/10/1998
Decision Date
09/08/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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