The following data is part of a premarket notification filed by Island Medical with the FDA for Muc-x.
| Device ID | K893204 |
| 510k Number | K893204 |
| Device Name: | MUC-X |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | ISLAND MEDICAL 2386 SHANNON RD. Fernandina Beach, FL 32034 |
| Contact | William J Schroder |
| Correspondent | William J Schroder ISLAND MEDICAL 2386 SHANNON RD. Fernandina Beach, FL 32034 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-26 |
| Decision Date | 1989-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H671IM71010FR0 | K893204 | 000 |
| H671IM7088FR0 | K893204 | 000 |