The following data is part of a premarket notification filed by Fetzer Medical Gmbh & Co.kg with the FDA for Self-retaining Retractor.
| Device ID | K161004 |
| 510k Number | K161004 |
| Device Name: | Self-retaining Retractor |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | FETZER MEDICAL GMBH & CO.KG UNTER BUCHSTEIG 5 Tuttlingen, DE 78532 |
| Contact | Harald Jung |
| Correspondent | Harald Jung FETZER MEDICAL GMBH & CO.KG UNTER BUCHSTEIG 5 Tuttlingen, DE 78532 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-11 |
| Decision Date | 2016-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887482175576 | K161004 | 000 |
| 00887482105337 | K161004 | 000 |
| 00887482105320 | K161004 | 000 |
| 00887482105313 | K161004 | 000 |
| 00887482105306 | K161004 | 000 |
| 00887482104545 | K161004 | 000 |
| 00887482056462 | K161004 | 000 |