The following data is part of a premarket notification filed by Kentron Health Care, Inc. with the FDA for Kensorb.
| Device ID | K953830 |
| 510k Number | K953830 |
| Device Name: | KENSORB |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | KENTRON HEALTH CARE, INC. 4330 SHERIDAN ST. Hollywood, FL 33021 |
| Contact | Nari Sadarangani |
| Correspondent | Nari Sadarangani KENTRON HEALTH CARE, INC. 4330 SHERIDAN ST. Hollywood, FL 33021 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-16 |
| Decision Date | 1995-10-03 |