The following data is part of a premarket notification filed by Rudolf Storz Gmbh with the FDA for Storz Raney Scalp Clip, Model 1-20-004-05.
| Device ID | K033660 |
| 510k Number | K033660 |
| Device Name: | STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 |
| Classification | Clip, Scalp |
| Applicant | RUDOLF STORZ GMBH AMSTEL 320-1 Amsterdam, NL 1017ap |
| Contact | Angelika Scherp |
| Correspondent | Angelika Scherp RUDOLF STORZ GMBH AMSTEL 320-1 Amsterdam, NL 1017ap |
| Product Code | HBO |
| CFR Regulation Number | 882.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-21 |
| Decision Date | 2004-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H834265911 | K033660 | 000 |
| 00887482192641 | K033660 | 000 |