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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