The following data is part of a premarket notification filed by Kerr Corporation (danbury) with the FDA for M4 Contra-angle Handpiece.
Device ID | K942480 |
510k Number | K942480 |
Device Name: | M4 CONTRA-ANGLE HANDPIECE |
Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
Applicant | KERR CORPORATION (DANBURY) 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
Contact | Jeffrey A Anderson |
Correspondent | Jeffrey A Anderson KERR CORPORATION (DANBURY) 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
Product Code | EGS |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-25 |
Decision Date | 1995-01-27 |