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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
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)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
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