510(k) K772171
K772171 is an FDA 510(k) premarket notification submitted by Robert C. Cameron for the device "EAR PIERCING DEVICE". The FDA issued a decision of Substantially Equivalent on January 3, 1978. 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
- January 3, 1978
- Date Received
- November 18, 1977
- 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