The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Warmtouch Plastic Warming Cover.
| Device ID | K943276 |
| 510k Number | K943276 |
| Device Name: | WARMTOUCH PLASTIC WARMING COVER |
| Classification | System, Thermal Regulating |
| Applicant | MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Contact | Jeffrey W Biggers |
| Correspondent | Jeffrey W Biggers MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-07 |
| Decision Date | 1994-09-19 |