The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Remote Vacuum Booster System, 7600 Series.
Device ID | K884103 |
510k Number | K884103 |
Device Name: | REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
Applicant | BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
Contact | Karpowicz, M.e. |
Correspondent | Karpowicz, M.e. BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
Product Code | GCX |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-29 |
Decision Date | 1989-03-03 |