510(k) K860622
K860622 is an FDA 510(k) premarket notification submitted by Onyx Industries, Inc. for the device "STUDEX EAR PIERCING GUNS". The FDA issued a decision of Substantially Equivalent on October 17, 1986. The device falls under product code JYS (Perforator, Ear-Lobe), a Class I device regulated under 21 CFR 874.4420.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 1986
- Date Received
- February 19, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Perforator, Ear-Lobe
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type