The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Boehringer Laboratories Suction Pump System.
| Device ID | K061788 |
| 510k Number | K061788 |
| Device Name: | BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | BOEHRINGER LABORATORIES 500 E. WASHINGTON ST. Norristown, PA 19401 |
| Contact | Christopher Radl |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-06-26 |
| Decision Date | 2006-07-11 |
| Summary: | summary |