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510(k) K864040

BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS by C.R. Bard, Inc. — Product Code FAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1986
Date Received
October 16, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Penile
Device Class
Class II
Regulation Number
876.3630
Review Panel
GU
Submission Type

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  • K963328 — AMS AMBICOR PENILE PROSTHESIS (December 4, 1996)
  • K953640 — DUNA II PENILE PROSTHESIS (October 27, 1995)
  • K951716 — AMS 650 MALLERABLE PENIEL PROSTHESIS (July 6, 1995)
  • K920420 — DURA II PENILE PROSTHESIS (April 16, 1992)
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