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FDA 510(k) Application Details - K973693
Device Classification Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
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510(K) Number
K973693
Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant
PCI TECHNOLOGY
10969 SHADY TRAIL
SUITE 101
DALLAS, TX 75220 US
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Contact
ROGER LIEBELT
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Regulation Number
000.0000
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Classification Product Code
MGQ
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More FDA Info for this Product Code
Date Received
09/26/1997
Decision Date
12/18/1997
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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