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510(k) K942351

DI ISOLATION GOWN by Derekduck Industries Corp. — Product Code FYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1995
Date Received
May 17, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Isolation, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Derekduck Industries Corp.

  • K940228 — BOUFFANT CAP (September 26, 1994)
  • K940226 — SHOE COVER (September 26, 1994)

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