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 |