SHARPLAN CO2 LAPAROSCOPIC PROBE MODEL 792 TO 792BX
FDA 510(k) clearance K894066 · decided 1989-08-10
Clearance details
- K-number
- K894066
- Device name
- SHARPLAN CO2 LAPAROSCOPIC PROBE MODEL 792 TO 792BX
- Applicant
- Sharplan Lasers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-06-08
- Decision date
- 1989-08-10
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.