The following data is part of a premarket notification filed by Pajunk Gmbh Medizintechnologie with the FDA for Special Sprotte, Chiba, Dr Steinhoff Kit.
| Device ID | K063697 |
| 510k Number | K063697 |
| Device Name: | SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT |
| Classification | Instrument, Biopsy |
| Applicant | PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 1 Geisingen, Baden-wurttemberg, DE 78187 |
| Contact | Christian Quass |
| Correspondent | Christian Quass PAJUNK GMBH MEDIZINTECHNOLOGIE KARL-HALL-STRASSE 1 Geisingen, Baden-wurttemberg, DE 78187 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-13 |
| Decision Date | 2007-02-14 |
| Summary: | summary |