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510(k) K820363

DISPOSABLE SURGICAL GARMENTS by Alphamedix, Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1982
Date Received
February 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
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)
  • K820008 — VERSATOME I (February 22, 1982)

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