510(k) K883785
K883785 is an FDA 510(k) premarket notification submitted by Gy-Ro Industry, Inc. for the device "GY-RO SAFE". The FDA issued a decision of Substantially Equivalent on January 5, 1989. The device falls under product code HOG (Burr, Corneal, Battery-Powered), a Class I device regulated under 21 CFR 886.4070.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 1989
- Date Received
- September 7, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Burr, Corneal, Battery-Powered
- Device Class
- Class I
- Regulation Number
- 886.4070
- Review Panel
- OP
- Submission Type