FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STUDEX EAR PIERCING GUNS
K Number: K860622
·
Decision Oct 17, 1986
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
2
Applicant Total
1
Review Days
240
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Basic Information
- Device Name
- STUDEX EAR PIERCING GUNS
- K Number
- K860622
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Onyx Industries, Inc.
- Date Received
- February 19, 1986
- Decision Date
- October 17, 1986
- Product Code
- JYS
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JYS | Perforator, Ear-Lobe | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JYS), ordered by most recent decision date.
J.K. TEMPLETON EAR PIERCING GUNS/INSTRUMENTS/STUDS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
EAR PIERCING DEVICE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat