The following data is part of a premarket notification filed by Broadline Medical Industries with the FDA for Gauze Sponges: Laparotomy Sponge, X-ray Detectable.
| Device ID | K990584 |
| 510k Number | K990584 |
| Device Name: | GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE |
| Classification | Gauze/sponge, Internal |
| 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 | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-23 |
| Decision Date | 1999-04-23 |