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 |