The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Grossman Self-retaining Low Profile Brain Retractor, Model 04-001-00.
| Device ID | K060097 |
| 510k Number | K060097 |
| Device Name: | GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00 |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | KLS-MARTIN L.P. 11239 ST. JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville, FL 32246 |
| Contact | Jennifer Damato |
| Correspondent | Jennifer Damato KLS-MARTIN L.P. 11239 ST. JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville, FL 32246 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-13 |
| Decision Date | 2006-02-27 |
| Summary: | summary |