The following data is part of a premarket notification filed by American Medical Electronics, Inc. with the FDA for Ogden Anchor Additional Applications.
| Device ID | K935065 |
| 510k Number | K935065 |
| Device Name: | OGDEN ANCHOR ADDITIONAL APPLICATIONS |
| Classification | Staple, Fixation, Bone |
| Applicant | AMERICAN MEDICAL ELECTRONICS, INC. 250 EAST ARAPAHO RD. Richardson, TX 75081 |
| Contact | Bruce Horowitz |
| Correspondent | Bruce Horowitz AMERICAN MEDICAL ELECTRONICS, INC. 250 EAST ARAPAHO RD. Richardson, TX 75081 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-20 |
| Decision Date | 1995-01-30 |