The following data is part of a premarket notification filed by Bioseal with the FDA for Gauze Sponge, X-ray Detectable.
| Device ID | K882708 |
| 510k Number | K882708 |
| Device Name: | GAUZE SPONGE, X-RAY DETECTABLE |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | BIOSEAL 350 NORTH PALM Brea, CA 92621 |
| Contact | William L Runion |
| Correspondent | William L Runion BIOSEAL 350 NORTH PALM Brea, CA 92621 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-27 |
| Decision Date | 1988-08-03 |