The following data is part of a premarket notification filed by Associated Medical Products Co. with the FDA for Custom Orthopaedic Trays (packs).
| Device ID | K930507 |
| 510k Number | K930507 |
| Device Name: | CUSTOM ORTHOPAEDIC TRAYS (PACKS) |
| Classification | Knife, Orthopedic |
| Applicant | ASSOCIATED MEDICAL PRODUCTS CO. 3250 GORHAM AVE. St. Louis Park, MN 55426 |
| Contact | Scott Wiest |
| Correspondent | Scott Wiest ASSOCIATED MEDICAL PRODUCTS CO. 3250 GORHAM AVE. St. Louis Park, MN 55426 |
| Product Code | HTS |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-01 |
| Decision Date | 1994-02-22 |