510(k) K991254
K991254 is an FDA 510(k) premarket notification submitted by Sub-Q, Inc. for the device "QS DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on August 23, 1999. The device falls under product code KYZ (Syringe, Irrigating (Non Dental)), a Class I device regulated under 21 CFR 880.6960. Sub-Q, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 1999
- Date Received
- April 13, 1999
- 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