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FDA 510(k) Application Details - K003396
Device Classification Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
More FDA Info for this Device
510(K) Number
K003396
Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant
WATER-JEL TECHNOLOGIES, LLC.
243 VETERANS BLVD.
CARLSTADT, NJ 07072 US
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Contact
MICHAEL PISANI
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MGQ
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More FDA Info for this Product Code
Date Received
11/01/2000
Decision Date
01/11/2001
Decision
SESE - SUBST EQUIV
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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