The following data is part of a premarket notification filed by Advanced Ortho-technology, Inc. with the FDA for Aquacel Surgical Prep Pads.
| Device ID | K854344 |
| 510k Number | K854344 |
| Device Name: | AQUACEL SURGICAL PREP PADS |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | ADVANCED ORTHO-TECHNOLOGY, INC. 150 MARBLEDALE RD. Tuckahoe, NY 10707 |
| Contact | Allen P Schlein |
| Correspondent | Allen P Schlein ADVANCED ORTHO-TECHNOLOGY, INC. 150 MARBLEDALE RD. Tuckahoe, NY 10707 |
| Product Code | GER |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-29 |
| Decision Date | 1985-11-13 |