510(k) K013747
- Device
- TEKNO-MEDICAL OBSTETRICAL FORCEPS
- Applicant
- TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO.
- 510(k) number
- K013747
- Product code
- HDA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-02-11
- Date received
- 2001-11-13
- Regulation
- 884.4400
- Classification name
- Forceps, Obstetrical
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARKUS DENK
- Address
- Kaiserstr. 9 Tuningen, B.W. DE 78609 78609
FDA Registration Numbers#
- 1058584
- 3023657851
- 3005809810
- 9710524
- 3007507973
- 3011024991
- 3004215117
- 2431166
- 3011137372
- 2647580
- 3011989923
- 3006554912
- 3007137643
- 1421879
- 1056350
- 3004001706
- 1417592
- 1423662
- 1836161
- 3017210488
- 3010041511
- 3008902714
- 1923569
- 3009465247
- 8040233
- 2916714
- 3003431869
- 3008770252
- 3035708926
- 3007773213
- 1123010
- 3015398570
- 9611283
- 9680518
- 3014279513
- 8010303
- 3018094310
- 3008711893
- 3015453963
- 8010168
- 2529846
- 1219930
- 1421101
- 3011585752
- 9616246
- 3014479313
- 8030607
- 9680519
- 1055890
- 3003418325
- 3014461810
- 3015895045
- 3012507533
- 3008864603
- 3031564283
- 3005528784
- 3009380063
- 9610612
- 3016965929
- 3033536312
- 3015972835
Source Documents#
Other 510(k) Records For Product Code HDA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100517 | INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX | Instrumed International, Inc. | 2010-04-29 |
| K092827 | DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX | Dimeda Instrumente GmbH | 2010-01-08 |
| K951529 | V. MUELLER OBSTETRICAL (OB) FORCEPS | Baxter Healthcare Corp | 1995-08-04 |
| K914552 | CMI VACUUM PUMP | Columbia Medical & Surgical, Inc. | 1993-09-07 |
| K905583 | ILC FORCEPS PADS | Inman Liebelt Corp. | 1991-04-12 |
| K903205 | AUTO SUTURE(R) ENDOSCOPIC CLAMP | United States Surgical, A Division of Tyco Healthc | 1990-10-11 |
| K890385 | MIDWIFERY/OBSTETRICAL FORCEPS | Kinetic Medical Products | 1989-03-01 |
| K851883 | SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420 | The Huxley Instrument Corp. | 1985-05-09 |
| K771106 | FORCEPS, OB, NON-COMPRESSIVE | Zeppelin Medizinlechnik GmbH | 1977-07-01 |
Legacy Summary#
summary
FDA Review#
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