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510(k) K851272

VERSAPHAGE by Alphamedix, Inc. — Product Code HQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1985
Date Received
April 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances by Alphamedix, Inc.

  • K852633 — VERSABLADE (November 4, 1985)
  • K852706 — VERSABLADE (November 4, 1985)
  • K830812 — ALPHAMEDIX I/A HAND-PIECE, 500-001 (June 8, 1983)
  • K830703 — GLOMARK (April 28, 1983)
  • K820363 — DISPOSABLE SURGICAL GARMENTS (March 8, 1982)
  • K820008 — VERSATOME I (February 22, 1982)

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  • K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTER (November 4, 2003)
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