The following data is part of a premarket notification filed by Medisiss with the FDA for Medisiss Reprocessed Ultrasonic Surgical Instruments.
| Device ID | K030598 |
| 510k Number | K030598 |
| Device Name: | MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS |
| Classification | Scalpel, Ultrasonic, Reprocessed |
| Applicant | MEDISISS 723 CURTIS COURT PO BOX 2060 Sisters, OR 97759 |
| Contact | Mary Ann Barker |
| Correspondent | Mary Ann Barker MEDISISS 723 CURTIS COURT PO BOX 2060 Sisters, OR 97759 |
| Product Code | NLQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-25 |
| Decision Date | 2004-01-23 |
| Summary: | summary |