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510(k) K030365

DEROYAL DRAPES, STERILE, NON-STERILE by Deroyal Industries, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2003
Date Received
February 4, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

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