STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS
FDA 510(k) clearance K852541 · decided 1985-07-11
Clearance details
- K-number
- K852541
- Device name
- STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS
- Applicant
- Storz Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-14
- Decision date
- 1985-07-11
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- GFI
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VALLEYLAB FORCE GSU HANDSET ADAPTER MODEL #E0500 (K933181) | Valleylab, Inc. | 1993-11-02 |
| ISI FENESTRATED DISSECTING AND GRASPING FORCEPS (K932534) | Innovative Surgical, Inc. | 1993-08-19 |
| HEMOLAB SILIMAT REAGENT (K920001) | Biomerieux Vitek, Inc. | 1992-09-25 |
| OSTEOTOMES, VARIOUS TYPES (K891887) | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| CHERMEL OSTEOTOMES (K842823) | Cher Mel Corp. | 1984-08-02 |
Recalls involving this device
No recalls on record reference this clearance.