The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Utk-dte Autilary Shield.
| Device ID | K954146 |
| 510k Number | K954146 |
| Device Name: | UTK-DTE AUTILARY SHIELD |
| Classification | Shield, Protective, Personnel |
| Applicant | MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Contact | Michael B Schoeck |
| Correspondent | Michael B Schoeck MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Product Code | KPY |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-05 |
| Decision Date | 1995-12-06 |