STUDEX EAR PIERCING GUNS
FDA 510(k) clearance K860622 · decided 1986-10-17
Clearance details
- K-number
- K860622
- Device name
- STUDEX EAR PIERCING GUNS
- Applicant
- Onyx Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-19
- Decision date
- 1986-10-17
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- JYS
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Harbor City, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| J.K. TEMPLETON EAR PIERCING GUNS/INSTRUMENTS/STUDS (K860678) | Jay Kenny Templeton | 1986-08-29 |
| EAR PIERCING DEVICE (K772171) | Robert C. Cameron | 1978-01-03 |
Recalls involving this device
No recalls on record reference this clearance.