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510(k) K970971

URO MED NERVE STIMULATOR by Uromed Corp. — Product Code ETN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1997
Date Received
March 17, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve
Device Class
Class II
Regulation Number
874.1820
Review Panel
EN
Submission Type

Other clearances by Uromed Corp.

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  • K993436 — CAVERMAP SURGICAL AID (February 11, 2000)
  • K982226 — UROMED BRACHYTHERAPHY IODINE-125 SOURCES (May 13, 1999)
  • K980717 — UROMED SLING KIT (May 22, 1998)
  • K974600 — UROMED PATCH (March 31, 1998)
  • K974137 — UROMED NEEDLE GRASPER (January 30, 1998)
  • K971992 — UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) (August 1, 1997)

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