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510(k) K934664

HYDRAGOWN by Mallinckrodt Group, Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1994
Date Received
September 28, 1993
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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  • K904145 — HYDRA VISION UROLOGICAL X-RAY SYSTEM (December 13, 1990)
  • K904147 — HUGH YOUNG II UROLOGICAL X-RAY SYSTEM (December 13, 1990)

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