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510(k) K831603

TITAN GE/IEPLATE by Helena Laboratories — Product Code JZR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1983
Date Received
May 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Support Gels
Device Class
Class I
Regulation Number
866.4900
Review Panel
IM
Submission Type

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