The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Osteotomy Bone Staple.
Device ID | K830255 |
510k Number | K830255 |
Device Name: | OSTEOTOMY BONE STAPLE |
Classification | Staple Driver |
Applicant | TECHMEDICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HXJ |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-25 |
Decision Date | 1983-03-09 |