The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Catr(tm)-h Cardiotomy Holder.
Device ID | K874867 |
510k Number | K874867 |
Device Name: | CATR(TM)-H CARDIOTOMY HOLDER |
Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
Applicant | BENTLEY LABORATORIES, INC. 17502 ARMSTRONG AVE. P.O. BOX 19522 Irvine, CA 92713 -9522 |
Contact | Merritt Girgis |
Correspondent | Merritt Girgis BENTLEY LABORATORIES, INC. 17502 ARMSTRONG AVE. P.O. BOX 19522 Irvine, CA 92713 -9522 |
Product Code | KPI |
CFR Regulation Number | 876.5320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-27 |
Decision Date | 1988-02-02 |