The following data is part of a premarket notification filed by Jay Kenny Templeton with the FDA for J.k. Templeton Ear Piercing Guns/instruments/studs.
Device ID | K860678 |
510k Number | K860678 |
Device Name: | J.K. TEMPLETON EAR PIERCING GUNS/INSTRUMENTS/STUDS |
Classification | Perforator, Ear-lobe |
Applicant | JAY KENNY TEMPLETON 628 W. NORTH MARKET BLVD., SUITE 1 Sacremento, CA 95834 |
Contact | Ken Templeton |
Correspondent | Ken Templeton JAY KENNY TEMPLETON 628 W. NORTH MARKET BLVD., SUITE 1 Sacremento, CA 95834 |
Product Code | JYS |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-25 |
Decision Date | 1986-08-29 |