The following data is part of a premarket notification filed by American Heyer Schulte with the FDA for Large Volume Closed Wound Suction Drain.
| Device ID | K822032 |
| 510k Number | K822032 |
| Device Name: | LARGE VOLUME CLOSED WOUND SUCTION DRAIN |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | AMERICAN HEYER SCHULTE 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-12 |
| Decision Date | 1982-08-16 |