The following data is part of a premarket notification filed by Isolyer Co. with the FDA for Isolyer (4x4, 8ply).
| Device ID | K940755 |
| 510k Number | K940755 |
| Device Name: | ISOLYER (4X4, 8PLY) |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | ISOLYER CO. 4320 INTERNATIONAL BLVD, NW NORCROSS, GA 30093 |
| Contact | TRAVIS HONEYCUTT |
| Correspondent | TRAVIS HONEYCUTT ISOLYER CO. 4320 INTERNATIONAL BLVD, NW NORCROSS, GA 30093 |
| 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 | 1994-02-18 |
| Decision Date | 1994-05-02 |