The following data is part of a premarket notification filed by Aesculap Instruments Corp. with the FDA for Aesculap Bone Mill.
Device ID | K860016 |
510k Number | K860016 |
Device Name: | AESCULAP BONE MILL |
Classification | Bone Mill |
Applicant | AESCULAP INSTRUMENTS CORP. 875 STANTON RD. Burlingame, CA 94010 |
Contact | Ron Allen |
Correspondent | Ron Allen AESCULAP INSTRUMENTS CORP. 875 STANTON RD. Burlingame, CA 94010 |
Product Code | LYS |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-03 |
Decision Date | 1986-03-19 |