510(k) K871816
K871816 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM". The FDA issued a decision of Substantially Equivalent on August 3, 1987. The device falls under product code EAY (Light, Fiber Optic, Dental), a Class I device regulated under 21 CFR 872.4620. Stryker Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 1987
- Date Received
- May 11, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Fiber Optic, Dental
- Device Class
- Class I
- Regulation Number
- 872.4620
- Review Panel
- DE
- Submission Type