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Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163492
510(k) Type
Special
Applicant
United states Endoscopy Group, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/6/2017
Days to Decision
24 days
Submission Type
Statement

Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163492
510(k) Type
Special
Applicant
United states Endoscopy Group, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/6/2017
Days to Decision
24 days
Submission Type
Statement