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ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162165
510(k) Type
Traditional
Applicant
SUMMIT MEDICAL PRODUCTS, INC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/29/2017
Days to Decision
391 days
Submission Type
Summary

ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162165
510(k) Type
Traditional
Applicant
SUMMIT MEDICAL PRODUCTS, INC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/29/2017
Days to Decision
391 days
Submission Type
Summary