510(k) K100852
- Device
- STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000
- Applicant
- STRYKER COMMUNICATIONS
- 510(k) number
- K100852
- Product code
- OCS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-05-06
- Date received
- 2010-03-26
- Regulation
- 876.1500
- Classification name
- Endoscopic Video Imaging System/component, Gastroenterology-urology
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- ALMA RELJA
- Address
- 1410 Lakeside Pkwy. #100 Flower Mound TX US 75028 75028
FDA Registration Numbers#
- 2242464
Source Documents#
Legacy Summary#
summary
FDA Review#
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