The following data is part of a premarket notification filed by Clincal Instruments Corp. with the FDA for Occlusion & Occlusion-irrigation.
| Device ID | K844918 |
| 510k Number | K844918 |
| Device Name: | OCCLUSION & OCCLUSION-IRRIGATION |
| Classification | Occluder, Catheter Tip |
| Applicant | CLINCAL INSTRUMENTS CORP. 9 CROSS ST. Dudley, MA 01570 |
| Contact | Michael L Polanyi |
| Correspondent | Michael L Polanyi CLINCAL INSTRUMENTS CORP. 9 CROSS ST. Dudley, MA 01570 |
| Product Code | DQT |
| CFR Regulation Number | 870.1370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-19 |
| Decision Date | 1985-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663102280 | K844918 | 000 |
| 00840663102273 | K844918 | 000 |
| 00840663102266 | K844918 | 000 |
| 00840663102259 | K844918 | 000 |