The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Anesthesia Breathing Circuit/anesthesia Breathing Kit.
| Device ID | K962045 |
| 510k Number | K962045 |
| Device Name: | ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT |
| Classification | Filter, Bacterial, Breathing-circuit |
| 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 | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1996-11-26 |