The following data is part of a premarket notification filed by American Medical Electronics, Inc. with the FDA for Expanded Range Of Suture Sizes Ogden Anchors: 7.4mm And 5.5mm.
| Device ID | K951232 |
| 510k Number | K951232 |
| Device Name: | EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM |
| Classification | Screw, Fixation, Bone |
| Applicant | AMERICAN MEDICAL ELECTRONICS, INC. 205 EAST ARAPAHO RD. Richardson, TX 75081 |
| Contact | Mary Biggers |
| Correspondent | Mary Biggers AMERICAN MEDICAL ELECTRONICS, INC. 205 EAST ARAPAHO RD. Richardson, TX 75081 |
| Product Code | HWC |
| Subsequent Product Code | JDR |
| Subsequent Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-20 |
| Decision Date | 1995-08-25 |