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 |