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510(k) K830667

SILICONE-SILVER PENILE PROSTHESIS-ESK by Dacomed Corp. — Product Code FTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1983
Date Received
March 4, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Penis, Rigid Rod
Device Class
Class II
Regulation Number
876.3630
Review Panel
GU
Submission Type

Other clearances by Dacomed Corp.

  • K953640 — DUNA II PENILE PROSTHESIS (October 27, 1995)
  • K941781 — RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM (August 25, 1994)
  • K920409 — DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE (May 11, 1992)
  • K920420 — DURA II PENILE PROSTHESIS (April 16, 1992)
  • K912344 — MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS (October 11, 1991)
  • K900774 — DACOMED NEGATIVE PRESSURE ERECTION DEVICE (May 4, 1990)
  • K885323 — DACOMED EXTERNAL MALE CONTINENCE DEVICE (February 8, 1989)
  • K880391 — DACOMED CYSTOMETER (April 27, 1988)
  • K871653 — DURAPHASE PENILE PROSTHESIS (September 18, 1987)
  • K870320 — DACOMED PENILE PROSTHESIS SIZER (March 17, 1987)

Other clearances for product code FTQ

  • K983015 — VIRILIS PENILE PROSTHESIS (February 5, 1999)