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510(k) K844703

GOWNS, SURGICAL by Medicon, Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1985
Date Received
December 3, 1984
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

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  • K844574 — WHEELCHAIRS (February 21, 1985)
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  • K844705 — SHOE COVERS (January 10, 1985)
  • K840034 — VACUUM STRETCHER IMMOBILIZER (February 27, 1984)

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