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FDA 510(k) Application Details - K980209
Device Classification Name
Dressing, Wound And Burn, Occlusive
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510(K) Number
K980209
Device Name
Dressing, Wound And Burn, Occlusive
Applicant
HOLLISTER, INC.
2000 HOLLISTER DR.
LIBERTYVILLE, IL 60048 US
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Contact
JOSEPH S TOKARZ
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
MGP
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More FDA Info for this Product Code
Date Received
01/20/1998
Decision Date
02/20/1998
Decision
SESK - SUBST EQUIV - KIT
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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