The following data is part of a premarket notification filed by Furlong Industries with the FDA for Non-absorbable Gauze For External Use, Sterile And Non Sterile.
Device ID | K991757 |
510k Number | K991757 |
Device Name: | NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE |
Classification | Gauze/sponge, Internal |
Applicant | FURLONG INDUSTRIES 311 N. SLUSSER ST. Grayslake, IL 60030 |
Contact | Pete Furlong |
Correspondent | Pete Furlong FURLONG INDUSTRIES 311 N. SLUSSER ST. Grayslake, IL 60030 |
Product Code | EFQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-05-24 |
Decision Date | 1999-08-12 |
Summary: | summary |