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510(k) K043494

MASTEL LASER CLEAN ROOM, MODEL EBS-100 by Mastel Precision Surgical Instruments, Inc. — Product Code FYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2005
Date Received
December 17, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type

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