510(k) K842992
K842992 is an FDA 510(k) premarket notification submitted by Norton Texas Medical Products for the device "GRASSHOPPER - RETRACTOR". The FDA issued a decision of Substantially Equivalent on August 17, 1984. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Norton Texas Medical Products has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 1984
- Date Received
- July 30, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retractor
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type