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Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)

Page Type
Cleared 510(K)
510(k) Number
K231003
510(k) Type
Traditional
Applicant
Guangdong OptoMedic Technologies, Inc.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
7/6/2023
Days to Decision
90 days
Submission Type
Summary

Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)

Page Type
Cleared 510(K)
510(k) Number
K231003
510(k) Type
Traditional
Applicant
Guangdong OptoMedic Technologies, Inc.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
7/6/2023
Days to Decision
90 days
Submission Type
Summary