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510(k) Data Aggregation
K Number
K992286Device Name
DERMAFREEZE
Manufacturer
Date Cleared
2000-01-21
(198 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
RHEALM PHARMACEUTICALS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DermaFreeze™ is a vapocoolant intended for topical application for the control of pain associated with minor surgical procedures (such as lancing boils, or incision and drainage of small abscesses), injections, and contusions.
Device Description
DermaFreeze™ is a vapocoolant
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