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510(k) K950030

HELIODENT MD by Pelton & Crane Co. — Product Code EAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1995
Date Received
January 4, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Intraoral
Device Class
Class II
Regulation Number
872.1810
Review Panel
RA
Submission Type

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