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Pre-Formed Penile Silicone Block

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162624
510(k) Type
Traditional
Applicant
INTERNATIONAL MEDICAL DEVICES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/1/2017
Days to Decision
134 days
Submission Type
Summary

Pre-Formed Penile Silicone Block

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162624
510(k) Type
Traditional
Applicant
INTERNATIONAL MEDICAL DEVICES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/1/2017
Days to Decision
134 days
Submission Type
Summary