4MM & 5MM FILE
FDA 510(k) clearance K841981 · decided 1984-06-19
Clearance details
- K-number
- K841981
- Device name
- 4MM & 5MM FILE
- Applicant
- Stainless Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-05-14
- Decision date
- 1984-06-19
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- HTP
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| INTERMEDICS ORTHOPEDICS REAMERS (K931733) | Intermedics Orthopedics | 1994-01-26 |
| SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP (K870842) | Warsaw Orthopedic, Inc. | 1987-05-27 |
| CONCEPT ARTHROSCOPY RASP (K862659) | Concept, Inc. | 1986-09-02 |
| SUN-LITE BLUE SLIT (K840492) | Suncoast Medical Manufacturers, Inc. | 1984-05-09 |
Recalls involving this device
No recalls on record reference this clearance.