The following data is part of a premarket notification filed by Team Mfg., Inc. with the FDA for Sterile Gauze Sponges X-ray Detectable.
| Device ID | K922054 |
| 510k Number | K922054 |
| Device Name: | STERILE GAUZE SPONGES X-RAY DETECTABLE |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | TEAM MFG., INC. P.O. BOX 15427 Augusta, GA 30919 |
| Contact | Norris R Harod |
| Correspondent | Norris R Harod TEAM MFG., INC. P.O. BOX 15427 Augusta, GA 30919 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-04 |
| Decision Date | 1992-08-10 |