The following data is part of a premarket notification filed by Associated Medical Products Co. with the FDA for C-section, Labor & Delivery Trays (packs).
| Device ID | K932216 |
| 510k Number | K932216 |
| Device Name: | C-SECTION, LABOR & DELIVERY TRAYS (PACKS) |
| Classification | Labor And Delivery Kit |
| Applicant | ASSOCIATED MEDICAL PRODUCTS CO. 3250 GORHAM AVE. St. Louis Park, MN 55426 |
| Contact | Scott Weiss |
| Correspondent | Scott Weiss ASSOCIATED MEDICAL PRODUCTS CO. 3250 GORHAM AVE. St. Louis Park, MN 55426 |
| Product Code | MLS |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-07 |
| Decision Date | 1994-04-19 |