The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Sponge, Richards Wound Drainage System.
| Device ID | K760257 |
| 510k Number | K760257 |
| Device Name: | SPONGE, RICHARDS WOUND DRAINAGE SYSTEM |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-07-19 |
| Decision Date | 1976-08-09 |