510(k) K943399
K943399 is an FDA 510(k) premarket notification submitted by Instantron for the device "THE SS-99". The FDA issued a decision of Substantially Equivalent on Sep 16, 1994. The device falls under product code KCW (Epilator, High Frequency, Needle-Type), a Class I device regulated under 21 CFR 878.5350. Instantron has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 16, 1994
- Date Received
- Jul 14, 1994
- 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
- 510(k) Exempt