The following data is part of a premarket notification filed by Solco Basle, Inc. with the FDA for Solcovac Wound Drainage System.
| Device ID | K915867 |
| 510k Number | K915867 |
| Device Name: | SOLCOVAC WOUND DRAINAGE SYSTEM |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | SOLCO BASLE, INC. 72 SHARP ST. HINGHAM CORPORATE CTR. Hingham, MA 02043 |
| Contact | Robert W Cunningham |
| Correspondent | Robert W Cunningham SOLCO BASLE, INC. 72 SHARP ST. HINGHAM CORPORATE CTR. Hingham, MA 02043 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-31 |
| Decision Date | 1992-08-14 |