The following data is part of a premarket notification filed by American Heyer Schulte with the FDA for Jackson-pratt Large Vol. Closed Wound.
| Device ID | K801766 |
| 510k Number | K801766 |
| Device Name: | JACKSON-PRATT LARGE VOL. CLOSED WOUND |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | AMERICAN HEYER SCHULTE 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 | 1980-07-28 |
| Decision Date | 1980-08-20 |