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510(k) K963220

TEMPRA COLD PACK, REORDER NO. TC150 by Tempo Technology, Inc. — Product Code IMD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1996
Date Received
August 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Disposable
Device Class
Class I
Regulation Number
890.5710
Review Panel
PM
Submission Type

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