FDA 510(k), K954237, CIRCUIT TREE PHACO HANDPIECE

FDA 510(k), K954237, CIRCUIT TREE PHACO HANDPIECE

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510(K) Number: K954237
Device Name: CIRCUIT TREE PHACO HANDPIECE
Manufacturer: GLENN A DUNKI-JACOBS
Device Classification Name: Unit, Phacofragmentation
Regulation Number: HQC
Classification Product Code: KXA
Date Received: 09/11/1995
Decision Date: 12/08/1995
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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