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510(k) K851158

VAN-TEC MEATAL DILATOR by Van-Tec, Inc. — Product Code KOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1985
Date Received
March 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Urethral
Device Class
Class II
Regulation Number
876.5520
Review Panel
GU
Submission Type

Other clearances by Van-Tec, Inc.

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  • K871779 — HELICAL STONE BASKET (DISPOSABLE) (June 17, 1987)
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  • K870557 — VAN-TEC PUMPING SYSTEM (March 30, 1987)
  • K870679 — VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE (March 30, 1987)

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