510(k) K930634

SUR FLO THERMAL THERAPY PADS by Buckman Co., Inc. — Product Code ILO

K930634 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "SUR FLO THERMAL THERAPY PADS". The FDA issued a decision of Substantially Equivalent on November 1, 1993. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1993
Date Received
February 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Water Circulating
Device Class
Class II
Regulation Number
890.5720
Review Panel
PM
Submission Type