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510(k) K151041

ERBECRYO 2 Cryosurgical Unit with accessories by Erbe USA, Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2015
Date Received
April 20, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

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