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510(k) K050895

SURPASSON P5 NEWTRON by Satelec — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2005
Date Received
April 8, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type

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  • K053328 — BIOSPLINT SPLINTING RIBBON (January 25, 2006)

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