510(k) K841100

HP-20, 30, 40, 50 & 60 by Associated Mills, Inc. — Product Code IRT

K841100 is an FDA 510(k) premarket notification submitted by Associated Mills, Inc. for the device "HP-20, 30, 40, 50 & 60". The FDA issued a decision of Substantially Equivalent on March 23, 1984. The device falls under product code IRT (Pad, Heating, Powered), a Class II device regulated under 21 CFR 890.5740. Associated Mills, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1984
Date Received
March 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Heating, Powered
Device Class
Class II
Regulation Number
890.5740
Review Panel
PM
Submission Type