510(k) K790738

HABITSABATER by Jackson Ent. — Product Code HCB

K790738 is an FDA 510(k) premarket notification submitted by Jackson Ent. for the device "HABITSABATER". The FDA issued a decision of Substantially Equivalent on June 20, 1979. The device falls under product code HCB (Device, Aversive Conditioning), a Class II device regulated under 21 CFR 882.5235.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1979
Date Received
April 16, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Aversive Conditioning
Device Class
Class II
Regulation Number
882.5235
Review Panel
NE
Submission Type