510(k) K931912
K931912 is an FDA 510(k) premarket notification submitted by Mayaguez Medical Center for the device "IRRIGATING BLUNT DISSECTOR". The FDA issued a decision of Substantially Equivalent on August 10, 1993. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Mayaguez Medical Center has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 1993
- Date Received
- April 16, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Irrigating (Non Dental)
- Device Class
- Class I
- Regulation Number
- 880.6960
- Review Panel
- HO
- Submission Type