The following data is part of a premarket notification filed by Integra Neurosciences with the FDA for Selector Integra Ultrasonic Surgical Aspirator, Model Om 1530000m3.
| Device ID | K021989 |
| 510k Number | K021989 |
| Device Name: | SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | INTEGRA NEUROSCIENCES 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
| Contact | Nancy Mathewson |
| Correspondent | Nancy Mathewson INTEGRA NEUROSCIENCES 5955 PACIFIC CENTER BLVD. San Diego, CA 92121 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-18 |
| Decision Date | 2002-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780040408 | K021989 | 000 |
| 10381780040224 | K021989 | 000 |
| M27315230151 | K021989 | 000 |
| M27315230141 | K021989 | 000 |
| M27315230161 | K021989 | 000 |
| M27315290631 | K021989 | 000 |
| M27315230771 | K021989 | 000 |
| M27315230781 | K021989 | 000 |
| M27315290651 | K021989 | 000 |
| M27315290641 | K021989 | 000 |
| M27315290661 | K021989 | 000 |
| M27315230431 | K021989 | 000 |
| 10381780040217 | K021989 | 000 |
| 10381780040200 | K021989 | 000 |
| 10381780040088 | K021989 | 000 |
| 10381780040095 | K021989 | 000 |
| 10381780040101 | K021989 | 000 |
| 10381780040118 | K021989 | 000 |
| 10381780040132 | K021989 | 000 |
| 10381780040149 | K021989 | 000 |
| 10381780040156 | K021989 | 000 |
| M27315230291 | K021989 | 000 |
| 10381780040170 | K021989 | 000 |
| 10381780040187 | K021989 | 000 |
| 10381780040194 | K021989 | 000 |
| M27315230321 | K021989 | 000 |
| 10381780121909 | K021989 | 000 |
| M27315230461 | K021989 | 000 |
| 10381780040057 | K021989 | 000 |
| 10381780040064 | K021989 | 000 |
| 10381780040071 | K021989 | 000 |
| 10381780040330 | K021989 | 000 |
| M27315230131 | K021989 | 000 |
| M27315230641 | K021989 | 000 |
| M27315230561 | K021989 | 000 |
| M27315230671 | K021989 | 000 |
| M27315230661 | K021989 | 000 |
| M27315290141 | K021989 | 000 |
| M27315230421 | K021989 | 000 |
| 10381780040040 | K021989 | 000 |
| 10381780040033 | K021989 | 000 |
| M27315230471 | K021989 | 000 |
| M27315231621 | K021989 | 000 |
| 10381780039945 | K021989 | 000 |
| 10381780039952 | K021989 | 000 |
| 10381780039969 | K021989 | 000 |
| 10381780039976 | K021989 | 000 |
| 10381780039983 | K021989 | 000 |
| 10381780039990 | K021989 | 000 |
| 10381780040002 | K021989 | 000 |
| 10381780040019 | K021989 | 000 |
| 10381780040026 | K021989 | 000 |
| 10381780121947 | K021989 | 000 |