CHERMEL OSTEOTOMES
FDA 510(k) clearance K842823 · decided 1984-08-02
Clearance details
- K-number
- K842823
- Device name
- CHERMEL OSTEOTOMES
- Applicant
- Cher Mel Corp.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-19
- Decision date
- 1984-08-02
- Days to decision
- 14 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
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cher Mel Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS (K852541) | Storz Instrument Co. | 1985-07-11 |
Recalls involving this device
No recalls on record reference this clearance.