The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Advance Disposable Control Syringe.
| Device ID | K911732 |
| 510k Number | K911732 |
| Device Name: | ADVANCE DISPOSABLE CONTROL SYRINGE |
| Classification | System, X-ray, Angiographic |
| Applicant | ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Contact | Ronald D Arkin |
| Correspondent | Ronald D Arkin ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-17 |
| Decision Date | 1991-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333209587 | K911732 | 000 |
| 20886333207330 | K911732 | 000 |
| 20886333207323 | K911732 | 000 |
| 20886333207316 | K911732 | 000 |
| 20886333207286 | K911732 | 000 |
| 20886333207279 | K911732 | 000 |
| 20886333207262 | K911732 | 000 |
| 20886333207248 | K911732 | 000 |
| 20886333207231 | K911732 | 000 |
| 20886333207224 | K911732 | 000 |
| 20886333207217 | K911732 | 000 |
| 20886333207200 | K911732 | 000 |
| 20886333207187 | K911732 | 000 |
| 20886333207170 | K911732 | 000 |
| 20886333209341 | K911732 | 000 |
| 20886333209358 | K911732 | 000 |
| 20886333209563 | K911732 | 000 |
| 20886333209556 | K911732 | 000 |
| 20886333209549 | K911732 | 000 |
| 20886333209471 | K911732 | 000 |
| 20886333209464 | K911732 | 000 |
| 20886333209440 | K911732 | 000 |
| 20886333209433 | K911732 | 000 |
| 20886333209426 | K911732 | 000 |
| 20886333209419 | K911732 | 000 |
| 20886333209402 | K911732 | 000 |
| 20886333209396 | K911732 | 000 |
| 20886333209389 | K911732 | 000 |
| 20886333209372 | K911732 | 000 |
| 20886333207163 | K911732 | 000 |