The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Scalp Dura Retractor, Model Ks00474.
| Device ID | K093054 |
| 510k Number | K093054 |
| Device Name: | SCALP DURA RETRACTOR, MODEL KS00474 |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Contact | Crystal Dizol |
| Correspondent | Crystal Dizol KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. El Segundo, CA 90245 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-30 |
| Decision Date | 2010-11-15 |
| Summary: | summary |