The following data is part of a premarket notification filed by Broadline Medical Industries with the FDA for Broadline Or Towels.
| Device ID | K991667 |
| 510k Number | K991667 |
| Device Name: | BROADLINE OR TOWELS |
| Classification | Drape, Surgical |
| Applicant | BROADLINE MEDICAL INDUSTRIES 1432 SHIRE CIRCLE Inverness, IL 60067 |
| Contact | Anna M Ramza |
| Correspondent | Anna M Ramza BROADLINE MEDICAL INDUSTRIES 1432 SHIRE CIRCLE Inverness, IL 60067 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-14 |
| Decision Date | 1999-09-27 |