The following data is part of a premarket notification filed by Gradipore Ltd. with the FDA for Gradiplasma La High, Gradiplasma La Low Models Lahp-1, Lahp-05, Lalp-1, Lalp-05.
| Device ID | K993332 |
| 510k Number | K993332 |
| Device Name: | GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 |
| Classification | Control, Plasma, Abnormal |
| Applicant | GRADIPORE LTD. LOT16 RIVERSIDE CORPORATE PARK 35-105 DELHI ROAD North Ryde, AU Nsw 2113 |
| Contact | Rhonda Pilgrim |
| Correspondent | Rhonda Pilgrim GRADIPORE LTD. LOT16 RIVERSIDE CORPORATE PARK 35-105 DELHI ROAD North Ryde, AU Nsw 2113 |
| Product Code | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-04 |
| Decision Date | 2000-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414023519 | K993332 | 000 |
| 00630414023502 | K993332 | 000 |
| 00842768008368 | K993332 | 000 |
| 00842768008351 | K993332 | 000 |
| 00842768019685 | K993332 | 000 |
| 00842768019678 | K993332 | 000 |