510(k) K871372
K871372 is an FDA 510(k) premarket notification submitted by R. A. Fischer Co. Corp. for the device "CB-7 ELECTRONIC EPILATOR". The FDA issued a decision of Substantially Equivalent on April 28, 1987. The device falls under product code KCW (Epilator, High Frequency, Needle-Type), a Class I device regulated under 21 CFR 878.5350. R. A. Fischer Co. Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 1987
- Date Received
- April 7, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Epilator, High Frequency, Needle-Type
- Device Class
- Class I
- Regulation Number
- 878.5350
- Review Panel
- SU
- Submission Type