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Premium Plus Disposable Barrier Sleeve

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163447
510(k) Type
Traditional
Applicant
PREMIUM PLUS INTERNATIONAL LIMITED
Country
China
FDA Decision
Substantially Equivalent
Decision Date
6/20/2017
Days to Decision
194 days
Submission Type
Summary

Premium Plus Disposable Barrier Sleeve

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163447
510(k) Type
Traditional
Applicant
PREMIUM PLUS INTERNATIONAL LIMITED
Country
China
FDA Decision
Substantially Equivalent
Decision Date
6/20/2017
Days to Decision
194 days
Submission Type
Summary