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510(k) K002702

NEUROTOLOGY DRAPE, MODEL TBD by Gyrus Ent LLC — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2000
Date Received
August 30, 2000
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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