The following data is part of a premarket notification filed by Hurricane Medical with the FDA for Tubing Extension Set.
| Device ID | K993361 |
| 510k Number | K993361 |
| Device Name: | TUBING EXTENSION SET |
| Classification | Tubing, Replacement, Phacofragmentation Unit |
| Applicant | HURRICANE MEDICAL 2331K 63RD AVE. EAST Bradenton, FL 34203 |
| Contact | David A Clapp |
| Correspondent | David A Clapp HURRICANE MEDICAL 2331K 63RD AVE. EAST Bradenton, FL 34203 |
| Product Code | MSR |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-06 |
| Decision Date | 2000-01-04 |
| Summary: | summary |