The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Autovac Closed Wound Suction System.
| Device ID | K930615 |
| 510k Number | K930615 |
| Device Name: | AUTOVAC CLOSED WOUND SUCTION SYSTEM |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
| Contact | John Karpowicz |
| Correspondent | John Karpowicz BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-05 |
| Decision Date | 1994-02-22 |