The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for T-vac Pleural Drainage Unit, 7800 Series.
Device ID | K861025 |
510k Number | K861025 |
Device Name: | T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES |
Classification | Bottle, Collection, Vacuum |
Applicant | BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
Contact | John Boehringer |
Correspondent | John Boehringer BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
Product Code | KDQ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-18 |
Decision Date | 1986-04-28 |