510(k) K972918
K972918 is an FDA 510(k) premarket notification submitted by Apex Medical Products, LLC for the device "RAPID FIRE HAIR IMPLANTER CAROUSEL". The FDA issued a decision of Substantially Equivalent on October 27, 1997. The device falls under product code GAH (Stylet, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 1997
- Date Received
- August 7, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stylet, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type