The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Boehringer Autovac(r) 7900 Series.
Device ID | K945775 |
510k Number | K945775 |
Device Name: | BOEHRINGER AUTOVAC(R) 7900 SERIES |
Classification | Apparatus, Autotransfusion |
Applicant | BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
Contact | John Karpowicz |
Correspondent | John Karpowicz BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
Product Code | CAC |
CFR Regulation Number | 868.5830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-25 |
Decision Date | 1995-10-19 |