The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Boehringer Laboratories Suction Intermittor.
Device ID | K853095 |
510k Number | K853095 |
Device Name: | BOEHRINGER LABORATORIES SUCTION INTERMITTOR |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
Applicant | BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
Contact | John R Boehringer |
Correspondent | John R Boehringer 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 | 1985-07-23 |
Decision Date | 1985-08-23 |