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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
K182258
510(k) Type
Special
Applicant
United States Endoscopy Group, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/21/2018
Days to Decision
31 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
K182258
510(k) Type
Special
Applicant
United States Endoscopy Group, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/21/2018
Days to Decision
31 days
Submission Type
Statement