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PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC

Page Type
Cleared 510(K)
510(k) Number
K132665
510(k) Type
Traditional
Applicant
ELLMAN INTERNATIONAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/25/2013
Days to Decision
29 days
Submission Type
Summary

PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC

Page Type
Cleared 510(K)
510(k) Number
K132665
510(k) Type
Traditional
Applicant
ELLMAN INTERNATIONAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/25/2013
Days to Decision
29 days
Submission Type
Summary