ENDOSCOPIC CAMERA
FDA 510(k) clearance K991416 · decided 1999-07-20
Clearance details
- K-number
- K991416
- Device name
- ENDOSCOPIC CAMERA
- Applicant
- Genzyme Surgical Product (Genzyme Biosurgery)
- Decision
- Substantially Equivalent
- Date received
- 1999-04-23
- Decision date
- 1999-07-20
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.