LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH
FDA 510(k) clearance K940141 · decided 1994-05-19
Clearance details
- K-number
- K940141
- Device name
- LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH
- Applicant
- Micro-Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-01-11
- Decision date
- 1994-05-19
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Castle Pines Village, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.