The following data is part of a premarket notification filed by Tekno Medical Optik-chirurgie Gmbh & Co. with the FDA for Tekno-medical Obstetrical Forceps.
| Device ID | K013747 |
| 510k Number | K013747 |
| Device Name: | TEKNO-MEDICAL OBSTETRICAL FORCEPS |
| Classification | Forceps, Obstetrical |
| Applicant | TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO. KAISERSTR 9 Tuningen, Baden-wurtenberg, DE 78609 |
| Contact | Markus Denk |
| Correspondent | Markus Denk TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO. KAISERSTR 9 Tuningen, Baden-wurtenberg, DE 78609 |
| Product Code | HDA |
| CFR Regulation Number | 884.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-13 |
| Decision Date | 2002-02-11 |
| Summary: | summary |