The following data is part of a premarket notification filed by Atlantic Surgical with the FDA for Laminated Karaya Gum Washers.
| Device ID | K820167 |
| 510k Number | K820167 |
| Device Name: | LAMINATED KARAYA GUM WASHERS |
| Classification | Collector, Ostomy |
| Applicant | ATLANTIC SURGICAL 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EXB |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-21 |
| Decision Date | 1982-02-18 |