510(k) K940371
K940371 is an FDA 510(k) premarket notification submitted by Micromedics, Inc. for the device "SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP". The FDA issued a decision of Substantially Equivalent on April 6, 1994. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Micromedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 1994
- Date Received
- January 6, 1994
- 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