The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Autovac Closed Wound Autotransfusion System,7920 S.
Device ID | K932093 |
510k Number | K932093 |
Device Name: | AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S |
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 | 1993-04-30 |
Decision Date | 1994-07-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
40816286020667 | K932093 | 000 |