The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Rasps For Scraping Bone.
Device ID | K771745 |
510k Number | K771745 |
Device Name: | RASPS FOR SCRAPING BONE |
Classification | Rasp |
Applicant | DEPUY, INC. 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 | 1977-09-15 |
Decision Date | 1977-09-28 |