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OMNI PHASE PENILE PROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K850019
510(k) Type
Traditional
Applicant
DACOMED CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/9/1985
Days to Decision
96 days

OMNI PHASE PENILE PROSTHESIS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K850019
510(k) Type
Traditional
Applicant
DACOMED CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/9/1985
Days to Decision
96 days