510(k) K802513
K802513 is an FDA 510(k) premarket notification submitted by Hill, Farrer & Borrill for the device "DPA 207 PERSONAL". The FDA issued a decision of Substantially Equivalent on December 16, 1980. The device falls under product code KCX (Epilator, High Frequency, Tweezer-Type), a Class I device regulated under 21 CFR 878.5360.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 1980
- Date Received
- October 15, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Epilator, High Frequency, Tweezer-Type
- Device Class
- Class I
- Regulation Number
- 878.5360
- Review Panel
- SU
- Submission Type