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Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle

Page Type
Cleared 510(K)
510(k) Number
K213831
510(k) Type
Special
Applicant
Gyrus ACMI, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/4/2022
Days to Decision
27 days
Submission Type
Summary

Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle

Page Type
Cleared 510(K)
510(k) Number
K213831
510(k) Type
Special
Applicant
Gyrus ACMI, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/4/2022
Days to Decision
27 days
Submission Type
Summary