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AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES

Page Type
Cleared 510(K)
510(k) Number
K122580
510(k) Type
Traditional
Applicant
ENCISION, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/9/2012
Days to Decision
78 days
Submission Type
Summary

AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES

Page Type
Cleared 510(K)
510(k) Number
K122580
510(k) Type
Traditional
Applicant
ENCISION, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/9/2012
Days to Decision
78 days
Submission Type
Summary