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Sphincterotome / short-wire compatible, Sterile Sphincterotome

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210934
510(k) Type
Traditional
Applicant
Micro-Tech (Nanjing) Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
12/1/2021
Days to Decision
247 days
Submission Type
Summary

Sphincterotome / short-wire compatible, Sterile Sphincterotome

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210934
510(k) Type
Traditional
Applicant
Micro-Tech (Nanjing) Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
12/1/2021
Days to Decision
247 days
Submission Type
Summary