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510(k) K941488

DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER by Medical Technology Development Corp. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1994
Date Received
March 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Medical Technology Development Corp.

  • K862315 — FYODOROV COLLAGEN CORNEAL SHIELD (January 7, 1987)
  • K863727 — FIXATION INSTRUMENTS (October 31, 1986)
  • K863725 — CATARACT DIAMOND KNIFE (October 31, 1986)
  • K863726 — INSTRUMENT STERILIZATION TRAY (October 14, 1986)

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