The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Ion Bond Osteotomes & Rasps, Fast Cu Burs.
| Device ID | K852541 |
| 510k Number | K852541 |
| Device Name: | STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS |
| Classification | Osteotome, Manual |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Dan Reagan |
| Correspondent | Dan Reagan STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | GFI |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-14 |
| Decision Date | 1985-07-11 |