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AquaShield system CO2, AquaShield system-PENTAX

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153362
510(k) Type
Special
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/16/2015
Days to Decision
26 days
Submission Type
Statement

AquaShield system CO2, AquaShield system-PENTAX

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153362
510(k) Type
Special
Applicant
UNITED STATES ENDOSCOPY GROUP, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/16/2015
Days to Decision
26 days
Submission Type
Statement