510(k) K960624

CERTI COOL INSTANT COLD COMPRESS by Certified Safety Mfg., Inc. — Product Code IMD

K960624 is an FDA 510(k) premarket notification submitted by Certified Safety Mfg., Inc. for the device "CERTI COOL INSTANT COLD COMPRESS". The FDA issued a decision of SN on May 6, 1996. The device falls under product code IMD (Pack, Hot Or Cold, Disposable), a Class I device regulated under 21 CFR 890.5710. Certified Safety Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
May 6, 1996
Date Received
February 13, 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