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510(k) K820008

VERSATOME I by Alphamedix, Inc. — Product Code HQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1982
Date Received
January 4, 1982
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)
  • K851272 — VERSAPHAGE (July 5, 1985)
  • K830812 — ALPHAMEDIX I/A HAND-PIECE, 500-001 (June 8, 1983)
  • K830703 — GLOMARK (April 28, 1983)
  • K820363 — DISPOSABLE SURGICAL GARMENTS (March 8, 1982)

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