The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Luer Lock Adapter/nut.
| Device ID | K862653 |
| 510k Number | K862653 |
| Device Name: | LUER LOCK ADAPTER/NUT |
| Classification | Set, Administration, Intravascular |
| Applicant | MALLINCKRODT CRITICAL CARE 675 MCDONNELL BLVD. P.O. BOX 5840 St Louis, MO 63134 |
| Contact | Carol L Mcnail-sabo |
| Correspondent | Carol L Mcnail-sabo MALLINCKRODT CRITICAL CARE 675 MCDONNELL BLVD. P.O. BOX 5840 St Louis, MO 63134 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-14 |
| Decision Date | 1986-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521184367 | K862653 | 000 |
| 10884521533042 | K862653 | 000 |
| 10884521537422 | K862653 | 000 |