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510(k) K122503

PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON by Neuro Therm, Inc. — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2013
Date Received
August 16, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Bone, Vertebroplasty
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

Other clearances by Neuro Therm, Inc.

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