510(k) K922348
K922348 is an FDA 510(k) premarket notification submitted by American Cyanamid Co. for the device "VALTRAC(R) INTRODUCER FORCEP". The FDA issued a decision of Substantially Equivalent on June 9, 1992. The device falls under product code HJE (Lamp, Fluorescein, Ac-Powered), a Class II device regulated under 21 CFR 878.4580. American Cyanamid Co. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 1992
- Date Received
- May 19, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Fluorescein, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type