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510(k) K884493

HEAD HOLDING DEVICE/SLEEP APNEA by X-Ray Systems — Product Code IWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1989
Date Received
October 26, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Head, Radiographic
Device Class
Class I
Regulation Number
892.1920
Review Panel
RA
Submission Type

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