510(k) K974190

CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER by Consolidated Products & Services, Inc. — Product Code IMD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1997
Date Received
November 4, 1997
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