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ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K132198
510(k) Type
Traditional
Applicant
CEREMED, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/12/2013
Days to Decision
58 days
Submission Type
Summary

ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K132198
510(k) Type
Traditional
Applicant
CEREMED, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/12/2013
Days to Decision
58 days
Submission Type
Summary