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INTRAcel RF Microneedle System

Page Type
Cleared 510(K)
510(k) Number
K183284
510(k) Type
Traditional
Applicant
Jeisys Medical Inc.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/15/2020
Days to Decision
415 days
Submission Type
Summary

INTRAcel RF Microneedle System

Page Type
Cleared 510(K)
510(k) Number
K183284
510(k) Type
Traditional
Applicant
Jeisys Medical Inc.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/15/2020
Days to Decision
415 days
Submission Type
Summary