The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Hi-care Closed Suction System.
| Device ID | K972258 |
| 510k Number | K972258 |
| Device Name: | HI-CARE CLOSED SUCTION SYSTEM |
| Classification | Catheters, Suction, Tracheobronchial |
| 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 | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-17 |
| Decision Date | 1997-12-29 |