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510(k) K043494

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

K043494 is an FDA 510(k) premarket notification submitted by Mastel Precision Surgical Instruments, Inc. for the device "MASTEL LASER CLEAN ROOM, MODEL EBS-100". The FDA issued a decision of Substantially Equivalent on October 4, 2005. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070.

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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FDA data resources