510(k) K924652
K924652 is an FDA 510(k) premarket notification submitted by Benson Medical Instruments Co. for the device "BENSON CCA100". The FDA issued a decision of Substantially Equivalent on April 9, 1993. The device falls under product code EWG (Laser, Ent Microsurgical Carbon-Dioxide), a Class II device regulated under 21 CFR 874.4500. Benson Medical Instruments Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 1993
- Date Received
- September 15, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Ent Microsurgical Carbon-Dioxide
- Device Class
- Class II
- Regulation Number
- 874.4500
- Review Panel
- EN
- Submission Type