The following data is part of a premarket notification filed by American Medical Electronics, Inc. with the FDA for Ogden Anchor.
| Device ID | K952348 |
| 510k Number | K952348 |
| Device Name: | OGDEN ANCHOR |
| Classification | Staple, Fixation, Bone |
| Applicant | AMERICAN MEDICAL ELECTRONICS, INC. 250 EAST ARAPAHO RD. Richardson, TX 75081 |
| Contact | Mary Biggers |
| Correspondent | Mary Biggers 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 | 1995-05-19 |
| Decision Date | 1995-08-21 |