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AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191559
510(k) Type
Special
Applicant
United States Endoscopy Group, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/1/2019
Days to Decision
49 days
Submission Type
Statement

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191559
510(k) Type
Special
Applicant
United States Endoscopy Group, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/1/2019
Days to Decision
49 days
Submission Type
Statement