510(k) K770170
K770170 is an FDA 510(k) premarket notification submitted by Techhnilab Instruments, Inc. for the device "MADDATHERM PARAFFIN BATH". The FDA issued a decision of Substantially Equivalent on January 28, 1977. The device falls under product code IMC (Bath, Paraffin), a Class II device regulated under 21 CFR 890.5110. Techhnilab Instruments, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 1977
- Date Received
- January 25, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bath, Paraffin
- Device Class
- Class II
- Regulation Number
- 890.5110
- Review Panel
- PM
- Submission Type