The following data is part of a premarket notification filed by A & M Instruments, Inc. with the FDA for Leblond Diamond Dental Bur.
Device ID | K833598 |
510k Number | K833598 |
Device Name: | LEBLOND DIAMOND DENTAL BUR |
Classification | Bur, Dental |
Applicant | A & M INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EJL |
CFR Regulation Number | 872.3240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-12 |
Decision Date | 1983-12-29 |