EXAMINER 10
FDA 510(k) clearance K781698 · decided 1978-11-03
Clearance details
- K-number
- K781698
- Device name
- EXAMINER 10
- Applicant
- American Sterilizer Co.
- Decision
- Substantially Equivalent
- Date received
- 1978-10-10
- Decision date
- 1978-11-03
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- HJE
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- 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 |
|---|---|---|
| VALTRAC(R) INTRODUCER FORCEP (K922348) | American Cyanamid Co. | 1992-06-09 |
| FLUORESCENT SUN LAMP FIXTURE (K802291) | Strato-Ray Co. | 1980-10-31 |
Recalls involving this device
No recalls on record reference this clearance.