The following data is part of a premarket notification filed by Dinkler Surgical Devices, Inc. with the FDA for Dinkler Surgical Skull Clamp, Model 0308.
| Device ID | K090695 |
| 510k Number | K090695 |
| Device Name: | DINKLER SURGICAL SKULL CLAMP, MODEL 0308 |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | DINKLER SURGICAL DEVICES, INC. 174 LOOKOUT DRIVE Dayton, OH 45419 |
| Contact | Charles E Dinkler Iii |
| Correspondent | Charles E Dinkler Iii DINKLER SURGICAL DEVICES, INC. 174 LOOKOUT DRIVE Dayton, OH 45419 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-16 |
| Decision Date | 2009-04-23 |
| Summary: | summary |