The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Bipal 7 /biopsy & Bipal Biopsy Forceps, Modif.
| Device ID | K933235 |
| 510k Number | K933235 |
| Device Name: | CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF |
| Classification | Tubing, Pump, Cardiopulmonary Bypass |
| Applicant | CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 -5700 |
| Contact | Tamara Harder |
| Correspondent | Tamara Harder CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 -5700 |
| Product Code | DWE |
| CFR Regulation Number | 870.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-19 |
| Decision Date | 1994-01-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032054963 | K933235 | 000 |
| 20705032054956 | K933235 | 000 |
| 20705032054949 | K933235 | 000 |