510(k) K790738
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 Jun 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
- Jun 20, 1979
- Date Received
- Apr 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