The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Woundfoam 4 X 4.
| Device ID | K953070 |
| 510k Number | K953070 |
| Device Name: | WOUNDFOAM 4 X 4 |
| Classification | Bandage, Liquid |
| Applicant | TRINITY LABORATORIES, INC. 201 KILEY DR. P.O. BOX 1818 Salisbury, MD 21802 |
| Contact | Partha Basumallik |
| Correspondent | Partha Basumallik TRINITY LABORATORIES, INC. 201 KILEY DR. P.O. BOX 1818 Salisbury, MD 21802 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-30 |
| Decision Date | 1995-09-08 |