The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Spirobac Adapters.
| Device ID | K944124 |
| 510k Number | K944124 |
| Device Name: | SPIROBAC ADAPTERS |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | MALLINCKRODT MEDICAL R.D. #1 BOX 1173 HOOK ROAD Argyle, NY 12809 |
| Contact | Frank J Steciuk |
| Correspondent | Frank J Steciuk MALLINCKRODT MEDICAL R.D. #1 BOX 1173 HOOK ROAD Argyle, NY 12809 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-23 |
| Decision Date | 1994-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884522032292 | K944124 | 000 |
| 10884522032070 | K944124 | 000 |