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 |