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SB Soft Hood - Straight type, SB Soft Hood - Undercut type

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173004
510(k) Type
Traditional
Applicant
Sumitomo Bakelite Co., Ltd
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
5/8/2018
Days to Decision
223 days
Submission Type
Summary

SB Soft Hood - Straight type, SB Soft Hood - Undercut type

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173004
510(k) Type
Traditional
Applicant
Sumitomo Bakelite Co., Ltd
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
5/8/2018
Days to Decision
223 days
Submission Type
Summary