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510(k) Data Aggregation
K Number
K973693Device Name
AQUA PATCH
Manufacturer
Date Cleared
1997-12-18
(83 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
PCI TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Dermal ulcers, superficial wounds, 1st and 2nd degree burns, donor sites, skin tears, radiation reactions (burns), protection around tube sites.
Device Description
Aqua Patch Hydrogel Dressing
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