The following data is part of a premarket notification filed by Amsco Co. with the FDA for Micro Rasps.
Device ID | K780771 |
510k Number | K780771 |
Device Name: | MICRO RASPS |
Classification | Rasp |
Applicant | AMSCO CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HTR |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-05-05 |
Decision Date | 1978-05-16 |