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510(k) K830812

ALPHAMEDIX I/A HAND-PIECE, 500-001 by Alphamedix, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1983
Date Received
March 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
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)
  • K830703 — GLOMARK (April 28, 1983)
  • K820363 — DISPOSABLE SURGICAL GARMENTS (March 8, 1982)
  • K820008 — VERSATOME I (February 22, 1982)

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