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NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K102616
510(k) Type
Traditional
Applicant
SMART MEDICAL SYSTEMS, LTD.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
12/30/2010
Days to Decision
111 days
Submission Type
Summary

NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K102616
510(k) Type
Traditional
Applicant
SMART MEDICAL SYSTEMS, LTD.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
12/30/2010
Days to Decision
111 days
Submission Type
Summary