The following data is part of a premarket notification filed by Fehling Medizintechnik Gmbh with the FDA for Myocard Biopsy Forcep.
| Device ID | K881412 |
| 510k Number | K881412 |
| Device Name: | MYOCARD BIOPSY FORCEP |
| Classification | Device, Biopsy, Endomyocardial |
| Applicant | FEHLING MEDIZINTECHNIK GMBH POSTFACH 1109, FRANKENSTRABE 21, D-8757 KARLSTEIN 1 West Germany, DE |
| Contact | Guido Fehling |
| Correspondent | Guido Fehling FEHLING MEDIZINTECHNIK GMBH POSTFACH 1109, FRANKENSTRABE 21, D-8757 KARLSTEIN 1 West Germany, DE |
| Product Code | DWZ |
| CFR Regulation Number | 870.4075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-04 |
| Decision Date | 1988-09-08 |