510(k) K801593
K801593 is an FDA 510(k) premarket notification submitted by Teledyne, Inc. for the device "LEBODY BY WATER PIK". The FDA issued a decision of Substantially Equivalent on Aug 20, 1980. The device falls under product code ISA (Massager, Therapeutic, Electric), a Class I device regulated under 21 CFR 890.5660. Teledyne, Inc. has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 20, 1980
- Date Received
- Jul 14, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Therapeutic, Electric
- Device Class
- Class I
- Regulation Number
- 890.5660
- Review Panel
- PM
- Submission Type
- 510(k) Exempt