OP-CON SURGICAL INSTRUMENTS #4
FDA 510(k) clearance K834173 · decided 1983-12-27
Clearance details
- K-number
- K834173
- Device name
- OP-CON SURGICAL INSTRUMENTS #4
- Applicant
- Imm Enterprises , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-21
- Decision date
- 1983-12-27
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- LBX
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.