Pre-market Notification Details
Device ID | K801886 |
510k Number | K801886 |
Device Name: | BURR, DENTAL |
Classification | Bur, Dental |
Applicant | AESCULAP INSTRUMENTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EJL |
CFR Regulation Number | 872.3240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-07-28 |
Decision Date | 1980-08-20 |
NIH GUDID Devices
Device Identifier | submissionNumber | Supplement |
00841685110505 |
K801886 |
000 |
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