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510(k) K083811

W&H HANDPIECE ANESTO, MODEL: RA-5 by W&H Dentalwerk Buermoos GmbH — Product Code EGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2010
Date Received
December 22, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Jet, Mechanical-Powered
Device Class
Class II
Regulation Number
872.4475
Review Panel
DE
Submission Type

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Other clearances for product code EGM

  • K243427 — QuickSleeper 5 (August 1, 2025)
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  • K904279 — PAROJECT ANESTHETIC SYRINGE (December 7, 1990)
  • K864294 — HENKE-JECT PRESSURE SYRINGE (MODIFICATION) (November 4, 1987)
  • K864732 — GRADTECH SYRINGE SYSTEM (April 15, 1987)
  • K864861 — INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM (February 13, 1987)
  • K834361 — JSB JET SYRINGE (March 5, 1984)
  • K821273 — MAYO SCISSOR STRAIGHT 6 3/4 (May 28, 1982)
  • K790193 — MIZZY SYRIJET MARK IV (April 23, 1979)